Registration Data Element Definitions

Attachment 1 - Registration Data Element Definitions (Reference Document).pdf

Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM)

Registration Data Element Definitions

OMB: 0925-0586

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ClinicalTrials.gov Protocol Registration Data Element
Definitions for Interventional and Observational Studies
(DRAFT)
January 18, 2017

This document describes the definitions for protocol registration data elements submitted to
ClinicalTrials.gov for interventional studies (clinical trials) and observational studies. These
definitions are mostly adapted from 42 CFR Part 11.
Data element entries are annotated with symbols to indicate generally what information is
required to be submitted (and under which circumstances). The responsible party must ensure
that the information provided complies with any applicable laws, regulations, or policies. For
more information about various requirements and definitions of regulatory terms under 42 CFR
Part 11, see Support Materials.
Note: The term "clinical study" is used to refer to both interventional and observational studies.
The term “participant” is used to refer to human subjects.

*
*§

Required

[*]

Conditionally required

Required if Study Start Date is on or after January 18, 2017

1. Study Identification

Unique Protocol Identification Number
Definition: Any unique identifier assigned to the protocol by the sponsor.
Limit: 30 characters.

Brief Title
Definition: A short title of the clinical study written in language intended for the lay
public.
Limit: 300 characters.
Acronym [*]
Definition: An acronym or abbreviation used publicly to identify the clinical

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study, if any.
Limit: 14 characters.

Official Title §
Definition: The title of the clinical study, corresponding to the title of the protocol.
Limit: 600 characters.
Secondary IDs [*]
Definition: An identifier(s), if any, other than the organization's Unique Protocol
Identification Number or the NCT number that is assigned to the clinical study. This
includes any unique clinical study identifiers assigned by other publicly available clinical
trial registries. If the clinical study is funded in whole or in part by a U.S. Federal
Government agency, the complete grant or contract number must be submitted as a
Secondary ID.
Limit: 30 characters.
If there is a Secondary ID, then the following information must be provided:
Secondary ID Type [*]
Definition: A description of the type of Secondary ID. Select one.
•

•

•
•

U.S. National Institute of Health (NIH) Grant/Contract Award Number: In
the Secondary ID field, include activity code, institute code and 6-digit
serial number. Other components of the full award number (type code,
support year and suffix) are optional.
Other Grant/Funding Number: Identifier assigned by a funding
organization other than the U.S. NIH; also required to enter the name of
the funding organization.
Registry Identifier: Number assigned by a clinical trial registry (for
example, a registry that is part of the World Health Organization [WHO]
Registry Network); also required to enter the name of the clinical trial
registry.
EudraCT Number: Identifier assigned by the European Medicines Agency
Clinical Trials Database (EudraCT).
Other Identifier: Also required to enter a brief description of the identifier
(for example, the name of organization that issued the identification
number).

Description [*]
Definition: If a Secondary ID Type of “Other Grant/Funding Number,” “Registry
Identifier,” or “Other Identifier” is selected, provide the name of the funding
organization, clinical trial registry, or organization that issued the identification
number.
Limit: 119 characters.

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Study Type
Definition: The nature of the investigation or investigational use for which clinical study
information is being submitted. Select one.
•

Interventional: Participants are assigned prospectively to an intervention or
interventions according to a protocol to evaluate the effect of the intervention(s)
on biomedical or other health related outcomes.

•

Observational: Studies in human beings in which biomedical and/or health
outcomes are assessed in pre-defined groups of individuals. Participants in the
study may receive diagnostic, therapeutic, or other interventions, but the
investigator does not assign specific interventions to the study participants. This
includes when participants receive interventions as part of routine medical care,
and a researcher studies the effect of the intervention.
•

Patient Registry
Definition: An observational study that is also considered to be a Patient
Registry. This type of study should only be registered once in the Protocol
Registration and Results System (PRS), by the sponsor responsible for the
primary data collection and analysis.
Note: The Agency for Healthcare Research and Quality (AHRQ) defines a
Patient Registry as including an organized system that uses observational
methods to collect uniform data (clinical and other) prospectively for a
population defined by a particular disorder/disease, condition (including
susceptibility to a disorder), or exposure (including products, healthcare
services, and/or procedures) and that serves a predetermined scientific,
clinical, or policy purpose. Patient registries may be single purpose or ongoing data collection programs that address one or more questions.

•

Expanded Access: An investigational drug product (including biological product)
available through expanded access for patients who do not qualify for enrollment
in a clinical trial. Expanded Access includes all expanded access types under
section 561 of the Federal Food, Drug, and Cosmetic Act: (1) for individual
patients, including emergency use; (2) for intermediate-size patient populations;
and (3) under a treatment IND or treatment protocol. (For more information on
data requirements for this Study Type, see ClinicalTrials.gov Registration Data
Element Definitions for Expanded Access).

2. Study Status

Record Verification Date
Definition: The date on which the responsible party last verified the clinical study

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information in the entire ClinicalTrials.gov record for the clinical study, even if no additional
or updated information is being submitted.

Overall Recruitment Status
Definition: The recruitment status for the clinical study as a whole, based upon the status of
the individual sites. If at least one facility in a multi-site clinical study has an Individual Site
Status of “Recruiting,” then the Overall Recruitment Status for the study must be
“Recruiting.” Select one.
•
•
•
•

•
•
•
•

Not yet recruiting: Participants are not yet being recruited
Recruiting: Participants are currently being recruited, whether or not any participants
have yet been enrolled
Enrolling by invitation: Participants are being (or will be) selected from a
predetermined population
Active, not recruiting: Study is continuing, meaning participants are receiving an
intervention or being examined, but new participants are not currently being recruited
or enrolled
Completed: The study has concluded normally; participants are no longer receiving
an intervention or being examined (that is, last participant’s last visit has occurred)
Suspended: Study halted prematurely but potentially will resume
Terminated: Study halted prematurely and will not resume; participants are no longer
being examined or receiving intervention
Withdrawn: Study halted prematurely, prior to enrollment of first participant

Why Study Stopped? §
Limit: 160 characters.
Definition: A brief explanation of the reason(s) why such clinical study was stopped
(for a clinical study that is “Suspended,” “Terminated,” or “Withdrawn” prior to its
planned completion as anticipated by the protocol).

Study Start Date §
Definition: The estimated date on which the clinical study will be open for recruitment of
participants, or the actual date on which the first participant was enrolled.
Note: "Enrolled" means a participant's, or their legally authorized representative’s, agreement
to participate in a clinical study following completion of the informed consent process.
Potential participants who are screened for the purpose of determining eligibility for the
study, but do not participate in the study, are not considered enrolled, unless otherwise
specified by the protocol.

Primary Completion Date
Definition: The date that the final participant was examined or received an intervention for

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the purposes of final collection of data for the primary outcome, whether the clinical study
concluded according to the pre-specified protocol or was terminated. In the case of clinical
studies with more than one primary outcome measure with different completion dates, this
term refers to the date on which data collection is completed for all of the primary outcomes.
Once the clinical study has reached the primary completion date, the responsible party must
update the Primary Completion Date to reflect the actual primary completion date.

Study Completion Date §
Definition: The date the final participant was examined or received an intervention for
purposes of final collection of data for the primary and secondary outcome measures and
adverse events (for example, last participant’s last visit), whether the clinical study concluded
according to the pre-specified protocol or was terminated.
Once the clinical study has reached the study completion date, the Responsible Party must
update the Study Completion Date to reflect the actual study completion date.

3. Sponsor/Collaborators

Responsible Party, by Official Title
Definition: An indication of whether the responsible party is the sponsor, the sponsorinvestigator, or a principal investigator designated by the sponsor to be the responsible party.
Select one.
•
•
•

Sponsor: The entity (for example, corporation or agency) that initiates the study
Principal Investigator: The individual designated as responsible party by the sponsor
(see Note)
Sponsor-Investigator: The individual who both initiates and conducts the study

Note: The sponsor may designate a principal investigator as the responsible party if such
principal investigator meets all of the following requirements: is responsible for conducting
the study; has access to and control over the data from the study; has the right to publish the
results of the study; and has the ability to meet all of the requirements for submitting and
updating clinical study information.
Investigator Information [*]
If the Responsible Party, by Official Title is either "Principal Investigator" or "SponsorInvestigator," the following is required:
Investigator Name: Name of the investigator, including first and last name

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Investigator Official Title: The official title of the investigator at the primary
organizational affiliation
Limit: 254 characters.
Investigator Affiliation: Primary organizational affiliation of the individual;
Limit: 160 characters.

Name of the Sponsor
Definition: The name of the entity or the individual who is the sponsor of the clinical study.
Limit: 160 characters.
Note: When a clinical study is conducted under an IND or investigational device exemption
(IDE), the IND or IDE holder is considered the sponsor. When a clinical study is not
conducted under an IND or IDE, the single person or entity who initiates the study, by
preparing and/or planning the study, and who has authority and control over the study, is
considered the sponsor.
Collaborators
Definition: Other organizations (if any) providing support, including funding, design,
implementation, data analysis and reporting. The responsible party is responsible for
confirming all collaborators before listing them.
Limit: 160 characters.

4. Oversight

Studies a U.S. FDA-regulated Device Product §
Definition: Indication that a clinical study is studying a device product subject to section
510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act. Select Yes/No.

Device Product Not Approved or Cleared by U.S. FDA § (formerly “Delayed
Posting?”)
Definition: Indication that at least one device product studied in the clinical study has
not been previously approved or cleared by the U.S. Food and Drug Administration
(FDA) for one or more uses. Select one.
•
•

Yes: At least one studied FDA-regulated device product has not been
previously approved or cleared by FDA
No: All studied FDA-regulated device products have been previously
approved or cleared by FDA

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Note: Full posting of registration information will be delayed if “Yes” is selected,
however the responsible party may authorize NIH to post the information using
the “Post Prior to U.S. FDA Approval or Clearance” data element.
Post Prior to U.S. FDA Approval or Clearance
Definition: Authorize NIH to post publicly clinical trial registration
information for a clinical study of a device product that has not been
previously approved or cleared (that would otherwise be subject to delayed
posting). Select Yes/No.
Pediatric Postmarket Surveillance of a Device Product [*]
Definition: Indication that a clinical study that includes a U.S. FDA-regulated
device product is a pediatric postmarket surveillance of a device product ordered
under section 522 of the Federal Food, Drug, and Cosmetic Act. Select Yes/No.

Studies a U.S. FDA-regulated Drug Product §
Definition: Indication that a clinical study studies a drug product (including a biological
product) subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to section
351 of the Public Health Service Act. Select Yes/No.
Investigational New Drug Application (IND)/Investigational Device Exemption (IDE)
Information
Definition: Complete the following information regarding an IND or IDE for the clinical
study as defined under U.S. Food and Drug Administration regulations in 21 CFR 312.3 or
21 CFR 812, respectively.

U.S. Food and Drug Administration IND or IDE Number
Definition: Indicate whether there is an IND or IDE for the clinical study. Select
Yes/No.
(Will not be made public - for administrative purposes only)
If there is an IND or IDE for the clinical study, the following is required:
FDA Center [*]
Definition: The name or abbreviation of the FDA Center with which the IND
or IDE is filed. Select one. (Will not be made public - for administrative
purposes only.)




CDER: Center for Drug Evaluation and Research
CBER: Center for Biologics Evaluation and Research
CDRH: Center for Devices and Radiological Health

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IND/IDE Number [*]
Definition: IND or IDE number assigned by the FDA Center. (Will not be
made public - for administrative purposes only.)
IND/IDE Serial Number [*]
Definition: For an IND, the IND serial number, as defined in 21 CFR
312.23(e), if any, assigned to the clinical study. (Will not be made public for administrative purposes only.)
Availability of Expanded Access [*]
Definition: Whether there is expanded access to the investigational
product for patients who do not qualify for enrollment in a clinical trial.
Expanded Access for investigational drug products (including biological
products) includes all expanded access types under section 561 of the
Federal Food, Drug, and Cosmetic Act: (1) for individual participants,
including emergency use; (2) for intermediate-size participant populations;
and (3) under a treatment IND or treatment protocol. Select one.
•
•
•

Yes: Investigational product is available through expanded access
No: Investigational product is not available through expanded
access
Unknown: If the responsible party is not the sponsor of the clinical
trial and manufacturer of the investigational product

Expanded Access Record NCT Number [*]
Definition: If expanded access is available, the NCT number of the
expanded access record. If there is no existing expanded access record,
the responsible party who is both the manufacturer of the
investigational drug product (including a biological product) and the
sponsor of the ACT is required to create an expanded access record.
(For more information on data requirements for this Study Type, see
ClinicalTrials.gov Registration Data Element Definitions for
Expanded Access).
Product Manufactured in and Exported from the U.S. [*]
Definition: Whether any drug product (including a biological product) or
device product studied in the clinical study is manufactured in the United
States or one of its territories and exported for study in a clinical study in
another country. Select Yes/No.

Human Subjects Review
Definition: Studies must have approval (or be exempt, as appropriate) from a Human
Subjects Protection Review Board prior to the enrollment of the first participant to be

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eligible for registration. A study may be submitted for registration prior to approval
by the review board so long as the study is not yet recruiting participants.

Human Subjects Protection Review Board Status
Definition: Indicate whether a clinical study has been reviewed and approved
by at least one human subjects protection review board or such review is not
required per applicable law (for example, 21 CFR Part 56, 45 CFR Part 46, or
other applicable regulation). Select one.
•
•
•
•
•
•

Request not yet submitted: Review board approval is required but
has not yet been requested
Submitted, pending: Review board approval has been requested
but not yet granted
Submitted, approved: Review board approval has been requested
and obtained
Exempt: An exemption in accord with applicable law and
regulation has been granted
Submitted, denied: Review board has denied the approval request
Submission not required: Review board approval is not required
because the study is not subject to laws, regulations, or applicable
institutional policies requiring human subjects review

If the study is not required to be registered under 42 CFR Part 11, is not
funded in whole or in part by the U.S. Government, or is not conducted
under an IND or IDE, then the following information is required:
Board Approval Number [*]
Definition: Number assigned by the human subjects review board upon
approval of the protocol. May be omitted if status is anything other than
approved. (Will not be made public - for administrative purposes only.)
Board Name [*]
Definition: Full name of the approving human subjects review board. (Will not
be made public - for administrative purposes only.)
Board Affiliation [*]
Definition: Official name of organizational affiliation of the approving human
subjects review board. (Will not be made public - for administrative purposes
only.)
Limit: 255 characters.

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Board Contact [*]
Definition: Contact information for the human subjects review board. (Will
not be made public - for administrative purposes only.)
•
•
•
•

Phone (or Email required): Phone number
Ext: Phone extension, if needed
Email (or Phone required): Electronic mail address.
Address: Mailing address for the board, including street address,
city, State or province, postal code, and country.

Data Monitoring Committee?
Definition: Indicate whether a data monitoring committee has been appointed
for this study. The data monitoring committee (board) is a group of
independent scientists who are appointed to monitor the safety and scientific
integrity of a human research intervention, and to make recommendations to
the sponsor regarding the stopping of the trial for efficacy, for harms or for
futility. The composition of the committee is dependent upon the scientific
skills and knowledge required for monitoring the particular study. Select
Yes/No.
Plan to Share IPD?
Definition: Indicate whether there is a plan to make individual participant data
(IPD) collected in this study available to other researchers (typically after the
end of the study). Select one.
•
•
•

Yes
No
Undecided

Plan Description
Definition: If IPD collected in this study are to be made available to
other researchers (typically after the end of the study), briefly describe
what participant data sets and/or documents are to be shared, when
data will be available, and how the data may be obtained. An
explanation may be provided for why IPD will not be shared.
Limit: 1000 characters.
FDA Regulated Intervention
Definition: Indicate whether this study includes an intervention subject to U.S. Food
and Drug Administration regulation under section 351 of the Public Health Service
Act or any of the following sections of the Federal Food, Drug, and Cosmetic Act:
505, 510(k), 515, 520(m), and 522. Select Yes/No.
Section 801 Clinical Trial
Definition: If this study includes an FDA regulated intervention, indicate

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whether this is an applicable clinical trial as defined in U.S. Public Law 11085, Title VIII, Section 801. Select Yes/No.

5. Study Description

Brief Summary
Definition: A short description of the clinical study, including a brief statement of the clinical
study's hypothesis, written in language intended for the lay public.
Limit: 5000 characters.
Detailed Description
Definition: Extended description of the protocol, including more technical information (as
compared to the Brief Summary), if desired. Do not include the entire protocol; do not
duplicate information recorded in other data elements, such as Eligibility Criteria or outcome
measures.
Limit: 32,000 characters.
For Patient Registries: Also describe the applicable registry procedures and other quality
factors (for example, third party certification, on-site audit). In particular, summarize any
procedures implemented as part of the patient registry, including, but not limited to the
following:
o
o
o

o
o

Quality assurance plan that addresses data validation and registry procedures,
including any plans for site monitoring and auditing.
Data checks to compare data entered into the registry against predefined rules for
range or consistency with other data fields in the registry.
Source data verification to assess the accuracy, completeness, or
representativeness of registry data by comparing the data to external data sources
(for example, medical records, paper or electronic case report forms, or interactive
voice response systems).
Data dictionary that contains detailed descriptions of each variable used by the
registry, including the source of the variable, coding information if used (for
example, World Health Organization Drug Dictionary, MedDRA), and normal
ranges if relevant.
Standard Operating Procedures to address registry operations and analysis
activities, such as patient recruitment, data collection, data management, data
analysis, reporting for adverse events, and change management.
Sample size assessment to specify the number of participants or participant years
necessary to demonstrate an effect.
Plan for missing data to address situations where variables are reported as
missing, unavailable, non-reported, uninterpretable, or considered missing
because of data inconsistency or out-of-range results.

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Statistical analysis plan describing the analytical principles and statistical
techniques to be employed in order to address the primary and secondary
objectives, as specified in the study protocol or plan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Definition: The name(s) of the disease(s) or condition(s) studied in the clinical study, or the
focus of the clinical study. Use, if available, appropriate descriptors from NLM's Medical
Subject Headings (MeSH)-controlled vocabulary thesaurus or terms from another
vocabulary, such as the Systematized Nomenclature of Medicine—Clinical Terms
(SNOMED CT), that has been mapped to MeSH within the Unified Medical Language
System (UMLS) Metathesaurus.
Keywords
Definition: Words or phrases that best describe the protocol. Keywords help users find
studies in the database. Use NLM's Medical Subject Heading (MeSH)-controlled vocabulary
terms where appropriate. Be as specific and precise as possible. Avoid acronyms and
abbreviations.

7. Study Design

(For interventional studies only)
Interventional Study Design
Definition: A description of the manner in which the clinical trial will be conducted,
including the following information:

Primary Purpose
Definition: The main objective of the intervention(s) being evaluated by the clinical
trial. Select one.
•
•
•
•

Treatment: One or more interventions are being evaluated for treating a
disease, syndrome, or condition.
Prevention: One or more interventions are being assessed for preventing
the development of a specific disease or health condition.
Diagnostic: One or more interventions are being evaluated for identifying
a disease or health condition.
Supportive Care: One or more interventions are evaluated for maximizing
comfort, minimizing side effects, or mitigating against a decline in the
participant's health or function.

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•

•
•

•

Screening: One or more interventions are assessed or examined for
identifying a condition, or risk factors for a condition, in people who are
not yet known to have the condition or risk factor.
Health Services Research: One or more interventions for evaluating the
delivery, processes, management, organization, or financing of healthcare.
Basic Science: One or more interventions for examining the basic
mechanism of action (for example, physiology or biomechanics of an
intervention).
Device Feasibility: An intervention of a device product is being evaluated
to determine the feasibility of the product or to test a prototype device and
not health outcomes. Such studies are conducted to confirm the design and
operating specifications of a device before beginning a full clinical trial.
Other: None of the other options applies.

Study Phase
Definition: For a clinical trial of a drug product (including a biological product), the
numerical phase of such clinical trial, consistent with terminology in 21 CFR
312.21and in 21 CFR 312.85 for phase 4 studies. Select only one.
•
•
•

•
•

•

N/A: Trials without phases (for example, studies of devices or behavioral
interventions).
Early Phase 1 (Formerly listed as “Phase 0”)
Phase 1: Includes initial studies to determine the metabolism and
pharmacologic actions of drugs in humans, the side effects associated with
increasing doses, and to gain early evidence of effectiveness; may include
healthy participants and/or patients.
Phase 1/Phase 2: Trials that are a combination of phases 1 and 2.
Phase 2: Includes controlled clinical studies conducted to evaluate the
effectiveness of the drug for a particular indication or indications in
participants with the disease or condition under study and to determine the
common short-term side effects and risks.
Phase 2/Phase 3: Trials that are a combination of phases 2 and 3.
Phase 3: Includes trials conducted after preliminary evidence suggesting
effectiveness of the drug has been obtained, and are intended to gather
additional information to evaluate the overall benefit-risk relationship of
the drug.
Phase 4: Studies of FDA-approved drugs to delineate additional
information including the drug's risks, benefits, and optimal use.

Intervention Model
Definition: The strategy for assigning interventions to participants.
•

Single Group: Clinical trials with a single arm

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•

Parallel: Participants are assigned to one of two or more groups in parallel
for the duration of the study are evaluated in parallel against a control
group
Cross-Over: Participants receive one of two (or more) alternative
interventions during the initial phase of the study and receive the other
intervention during the second phase of the study are evaluated in parallel
against a control group
Factorial: Two or more interventions, each alone and in combination, are
evaluated in parallel against a control group are evaluated in parallel
against a control group
Sequential: Groups of participants are assigned to receive interventions
based on prior milestones being reached in the study, such as in some dose
escalation and adaptive design studies are evaluated in parallel against a
control group

Model Description
Definition: Provide details about the Interventional Study Model.
Limit: 1000 characters.

Number of Arms §
Definition: The number of arms in the clinical trial. For a trial with multiple periods
or phases that have different numbers of arms, the maximum number of arms during
all periods or phases.
Note: “Arm” means a pre-specified group or subgroup of participant(s) in a clinical
trial assigned to receive specific intervention(s) (or no intervention) according to a
protocol.

Masking §
Definition: The party or parties involved in the clinical trial who are prevented from
having knowledge of the interventions assigned to individual participants. Select all
that apply.
•
•

No Masking
Roles, if Masking:
• Participant
• Care Provider
• Investigator
• Outcomes Assessor: The individual who evaluates the outcome(s)
of interest

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Masking Description
Definition: Provide information about other parties who may be masked in the
clinical trial, if any.
Limit: 1000 characters.

Allocation §
Definition: The method by which participants are assigned to arms in a clinical trial.
•
•
•

Randomized: Participants are assigned to intervention groups by chance
Nonrandomized: Participants are expressly assigned to intervention groups
through a non-random method, such as physician choice
Not applicable: For a single-arm trial

Enrollment §
Definition: The estimated total number of participants to be enrolled (target number)
or the actual total number of participants that are enrolled in the clinical study.
Note: “Enrolled” means a participant’s, or their legally authorized representative’s,
agreement to participate in a clinical study following completion of the informed
consent process. Potential participants who are screened for the purpose of
determining eligibility for a study, but do not participate in the study, are not
considered enrolled, unless otherwise specified by the protocol.
Observational Study Design (For observational studies only)

Observational Study Model
Definition: Primary strategy for participant identification and follow-up. Select one.
•

•

•
•

•

Cohort: Group of individuals, initially defined and composed, with
common characteristics (for example, condition, birth year), who are
examined or traced over a given time period.
Case-Control: Group of individuals with specific characteristics (for
example, conditions or exposures) compared to group(s) with different
characteristics, but otherwise similar.
Case-Only: Single group of individuals with specific characteristics.
Case-Crossover: Characteristics of case immediately prior to disease onset
(sometimes called the hazard period) compared to characteristics of same
case at a prior time (that is, control period).
Ecologic or Community Studies: Geographically defined populations,
such as countries or regions within a country, compared on a variety of
environmental (for example, air pollution intensity, hours of sunlight)
and/or global measures not reducible to individual level characteristics

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•
•

(for example, healthcare system, laws or policies median income, average
fat intake, disease rate).
Family-Based: Studies conducted among family members, such as genetic
studies within families or twin studies and studies of family environment.
Other: Explain in Detailed Description.

Time Perspective
Definition: Temporal relationship of observation period to time of participant
enrollment. Select one.
•
•
•
•

Prospective: look forward using periodic observations collected
predominantly following subject enrollment
Retrospective: look back using observations collected predominantly prior
to subject selection and enrollment
Cross-sectional: observations or measurements made at a single point in
time, usually at subject enrollment
Other - explain in Detailed Description

Biospecimen Retention
Definition: Indicate whether samples of material from research participants are
retained in a biorepository. Select one:
•
•

•

None Retained - no samples retained
Samples With DNA - samples retained, with potential for extraction of
DNA from at least one of the types of samples retained (e.g., frozen tissue,
whole blood)
Samples Without DNA - samples retained, with no potential for DNA
extraction from any retained samples (e.g., fixed tissue, plasma)

Biospecimen Description
Definition: Specify all types of biospecimens to be retained (e.g., whole blood, serum,
white cells, urine, tissue).
Limit: 1000 characters.

Enrollment
Definition: The estimated total number of participants to be enrolled (target number)
or the actual total number of participants that are enrolled in the clinical study.
Note: “Enrolled” means a participant’s, or their legally authorized representative’s,
agreement to participate in a clinical study following completion of the informed
consent process. Potential participants who are screened for the purpose of
determining eligibility for a study, but do not participate in the study, are not
considered enrolled, unless otherwise specified by the protocol.

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Target Follow-Up Duration
Definition: For Patient Registries, the anticipated time period over which each
participant is to be followed. Provide a number and select a Unit of Time (years,
months, weeks, days).

Number of Groups/Cohorts
Definition: Number of study groups/cohorts. Enter “1” for a single-group study.
Many observational studies have one group/cohort; case control studies typically have
two.

8. Arms, Groups, and Interventions

Arm Information
(For interventional studies only)
Definition: A description of each arm of the clinical trial that indicates its role in the clinical
trial; provides an informative title; and, if necessary, additional descriptive information
(including which interventions are administered in each arm) to differentiate each arm from
other arms in the clinical trial.
Note: "Arm" means a pre-specified group or subgroup of participant(s) in a clinical trial
assigned to receive specific intervention(s) (or no intervention) according to a protocol.

Arm Title
Definition: The short name used to identify the arm.
Limit: 62 characters.

Arm Type
Definition: The role of each arm in the clinical trial.
•
•
•
•
•
•

Experimental
Active Comparator
Placebo Comparator
Sham Comparator
No intervention
Other

Arm Description [*]
Definition: If needed, additional descriptive information (including which
interventions are administered in each arm) to differentiate each arm from

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other arms in the clinical trial.
Limit: 999 characters.

Arm/Intervention Cross-Reference
Definition: If multiple Arms have been specified, indicate which Interventions are
administered in each Arm of the study, using the Cross-Reference check boxes.
Groups/Cohort Information (For observational studies only)
Definition: Specify the predefined participant groups (cohorts) to be studied,
corresponding to Number of Groups specified under Study Design (for single-group
studies, the following data elements are optional). Do not use this section to specify strata
(Detailed Description can be used for that purpose, if desired).
Limit: 62 characters.

Group/Cohort Label
Definition: The short name used to identify the group.
Group/Cohort Description [*]
Definition: Explanation of the nature of the study group (for example, those
with a condition and those without a condition; those with an exposure and
those without an exposure).
Limit: 1000 characters.
Note: The overall study population should be described under Eligibility.

Interventions:
Definition: Specify the intervention(s) associated with each arm or group; at least one
intervention must be specified for interventional studies. For observational studies,
specify the intervention(s)/exposure(s) of interest, if any. If the same intervention is
associated with more than one arm or group, provide the information once and use the
Arm/Intervention Cross-Reference to associate it with more than one arm or group.

Intervention Type
Definition: For each intervention studied in the clinical study, the general type of
intervention. Select one.
•
•
•
•
•
•

Drug: Including placebo
Device: Including sham
Biological/Vaccine
Procedure/Surgery
Radiation
Behavioral: For example, psychotherapy, lifestyle counseling

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•
•
•

•
•

Genetic: Including gene transfer, stem cell and recombinant DNA
Dietary Supplement: For example, vitamins, minerals
Combination Product: Combining a drug and device, a biological product
and device; a drug and biological product; or a drug, biological product,
and device
Diagnostic Test: For example, imaging, in-vitro
Other

Intervention Name(s)
Definition: A brief descriptive name used to refer to the intervention(s) studied in
each arm of the clinical study. A non-proprietary name of the intervention must be
used, if available. If a non-proprietary name is not available, a brief descriptive name
or identifier must be used.
Limit: 200 characters.
Other Intervention Name(s) [*]
Definition: Other current and former name(s) or alias(es), if any, different
from the Intervention Name(s), that the sponsor has used publicly to identify
the intervention(s), including, but not limited to, past or present names such as
brand name(s), or serial numbers.
Limit: 200 characters.

Intervention Description §
Definition: Details that can be made public about the intervention, other than the
Intervention Name(s) and Other Intervention Name(s), sufficient to distinguish the
intervention from other, similar interventions studied in the same or another clinical
study. For example, interventions involving drugs may include dosage form, dosage,
frequency, and duration.
Limit: 1000 characters.

9. Outcome Measures

Primary Outcome Measure Information
Definition: A description of each primary outcome measure (or for observational studies,
specific key measurement[s] or observation[s] used to describe patterns of diseases or traits
or associations with exposures, risk factors or treatment).
Note: "Primary outcome measure" means the outcome measure(s) of greatest importance
specified in the protocol, usually the one(s) used in the power calculation. Most clinical
studies have one primary outcome measure, but a clinical study may have more than one.

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For each primary outcome measure, include the following information:

Title:
Name of the specific primary outcome measure
Limit: 254 characters.

Description: § Description of the metric used to characterize the specific primary
outcome measure
Limit: 999 characters.

Time Frame:
Time point(s) at which the measurement is assessed for the specific
metric used. The description of the time point(s) of assessment must be specific to the
outcome measure and is generally the specific duration of time over which each
participant is assessed (not the overall duration of the study).
Limit: 254 characters.

Secondary Outcome Measure Information [*]
Definition: A description of each secondary outcome measure (or for observational studies,
specific secondary measurement[s] or observation[s] used to describe patterns of diseases or
traits or associations with exposures, risk factors or treatment).
Note: "Secondary outcome measure" means an outcome measure that is of lesser importance
than a primary outcome measure, but is part of a pre-specified analysis plan for evaluating
the effects of the intervention or interventions under investigation in a clinical study and is
not specified as an exploratory or other measure. A clinical study may have more than one
secondary outcome measure.
For each secondary outcome measure, include the following information:

o
o

* Name of the specific secondary outcome measure
Description: *§ Description of the metric used to characterize the specific
Title:

secondary outcome measure
o

Other Pre-specified Outcome Measures
Definition: Any other measurements, excluding post-hoc measures, that will be used to
evaluate the intervention(s) or, for observational studies, that are a focus of the study.

Title:

* Name of the specific other pre-specified outcome measure
20

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Description: § Description of the metric used to characterize the specific other prespecified outcome measure

10. Eligibility

Sex/Gender
Definition: The sex and, if applicable, gender of the participants eligible to participate in the
clinical study.

Sex
Definition: The sex of the participants eligible to participate in the clinical study.
Select one.
Note: "Sex" means a person's classification as male or female based on biological
distinctions.
•
•
•

Male: Indicates that only male participants are being studied
Female: Indicates that only female participants are being studied
All: Indicates no limit on eligibility based on the sex of participants

Gender [*]
Definition: If applicable, indicate whether participant eligibility is based on
gender. Select one.
Note: "Gender" means a person's self-representation of gender identity.
•
•

Yes: Eligibility is based on gender
No: Eligibility is not based on gender

Gender Eligibility Description
Definition: If eligibility is based on gender, provide descriptive
information about Gender criteria.
Limit: 1000 characters.

Age Limits
Definition: The minimum and maximum age of potential participants eligible for the clinical
study, provided in relevant units of time.

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Minimum Age
Definition: The numerical value, if any, for the minimum age a potential participant
must meet to be eligible for the clinical study.
Unit of Time
Select one.
•
•
•
•
•
•
•

Years
Months
Weeks
Days
Hours
Minutes
N/A (No Limit)

Maximum Age
Definition: The numerical value, if any, for the maximum age a potential participant
can be to be eligible for the clinical study.
Unit of Time
Select one.
•
•
•
•
•
•
•

Years
Months
Weeks
Days
Hours
Minutes
N/A (No Limit)

Accepts Healthy Volunteers? §
Definition: Indication that participants who do not have a disease or condition, or related
conditions or symptoms, under study in the clinical study are permitted to participate in the
clinical study. Select Yes/No.

Eligibility Criteria
Definition: A limited list of criteria for selection of participants in the clinical study, provided
in terms of inclusion and exclusion criteria and suitable for assisting potential participants in
identifying clinical studies of interest. Use a bulleted list for each criterion below the headers

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"Inclusion Criteria" and "Exclusion Criteria".
Limit: 15,000 characters.

Study Population Description
(For observational studies only)
Definition: A description of the population from which the groups or cohorts will be selected
(for example, primary care clinic, community sample, residents of a certain town).
Limit: 1000 characters.

Sampling Method
(For observational studies only)
Definition: Indicate the method used for the sampling approach and explain in the Detailed
Description. Select one.
•

•

Probability Sample: Exclusively random process to guarantee that each
participant or population has specified chance of selection, such as simple random
sampling, systematic sampling, stratified random sampling, cluster sampling, and
consecutive participant sampling
Non-Probability Sample: Any of a variety of other sampling processes, such as
convenience sampling or invitation to volunteer

11. Contacts, Locations, and Investigator Information

(or Facility Contact required)
Central Contact Person
Definition: The name or title, toll-free telephone number and email address of a person to
whom questions concerning enrollment at any location of the study can be addressed. Include
the following information:
•
•

First Name
Middle Initial

•

Last Name or Official Title
Degree

•
•

•

Phone:
Toll free phone number of the Central Contact Person. Use the format
800-555-5555 within the United States and Canada. If outside the United States
and Canada, provide the full phone number, including the country code.
Ext: phone extension, if needed

•

Email:

* electronic mail address of the central contact person

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Central Contact Backup
Definition: Person to contact if Central Contact is not available. Include the following
information:
•
•
•
•
•

•
•

First Name
Middle Initial
Last Name or Official Title
Degree
Phone: Toll free phone number of the Central Contact Backup. Use the format
800-555-5555 within the United States and Canada. If outside the United States
and Canada, provide the full phone number, including the country code.
Ext: Phone extension, if needed
Email: Electronic mail address of the contact person

Overall Study Officials
Definition: Person(s) responsible for the overall scientific leadership of the protocol,
including study principal investigator. Include the following information:
•
•
•
•
•

•

First Name
Middle Initial
Last Name
Degree
Organizational Affiliation: Full name of the official's organization. If none,
specify Unaffiliated.
Limit: 255 characters.
Official's Role: Position or function of the official. Select one
 Study Chair
 Study Directori
 Study Principal Investigator

Facility Information
Definition: For each participating facility in a clinical study, the following information:

•

Facility Name: § Full name of the organization where the clinical study is
being conducted.
Limit: 254 characters.

•

City

•

State/Province:
States)

•

ZIP/Postal Code:
United States)

*
* Required for U.S. locations (including territories of the United
*§ Required for U.S. locations (including territories of the
24

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Country

*
*

Individual Site Status
Definition: The recruitment status of each participating facility in a clinical study.
•
•
•
•

•

•
•
•

Not yet recruiting: Participants are not yet being recruited
Recruiting: Participants are currently being recruited, whether or not any
participants have yet been enrolled
Enrolling by invitation: Participants are being, or will be selected from a
predetermined population
Active, not recruiting: Study is continuing, meaning participants are receiving an
intervention or being examined, but new participants are not currently being
recruited or enrolled
Completed: The study has concluded normally; participants are no longer
receiving an intervention or being examined (that is, the last participant's last visit
has occurred)
Suspended: Study halted prematurely but potentially will resume
Terminated: Study halted prematurely and will not resume; participants are no
longer being examined or receiving intervention
Withdrawn: Study halted prematurely, prior to enrollment of first participant

Facility Contact (or Central Contact required)
Definition: For each facility participating in a clinical study, including the name or title,
telephone number, and email address of a person to whom questions concerning the study
and enrollment at that site can be addressed. Include the following information:
•
•

First Name
Middle Initial

•

Last Name or Official Title
Degree

•
•

•

Phone:
Office phone of the Facility Contact.
Ext: phone extension, if needed

•

Email:

* Electronic mail address of the facility contact person

Facility Contact Backup
Definition: Person to contact if Facility Contact is not available (that is, a second contact
person).
Investigators (at the facility location). Include the following information:

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•
•
•
•
•

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First Name
Middle Initial
Last Name
Degree
Role:
• Site Principal Investigator
• Site Sub-Investigator

Contact information character limits:
•
•
•
•
•
•
•

First Name: 62 characters
Last Name: 62 characters
Degree: 30 characters
Phone: 30 characters
Phone Ext: 14 characters
Email: 254 characters
Affiliation: 160 characters

12. References
Citations
Definition: Citations to publications related to the protocol: background and/or results.
Provide either the PubMed Unique Identifier (PMID) of an article or enter the full
bibliographic citation.
PubMed Identifier
Definition: PMID for the citation in MEDLINE
Citation
Definition: bibliographic reference in NLM's MEDLINE format
Limit: 2000 characters.
Results Reference?
Definition: Indicate if the reference provided reports on results from this clinical
study.

Links
Definition: A Web site directly relevant to the protocol may be entered, if desired. Do not
include sites whose primary goal is to advertise or sell commercial products or services.
Links to educational, research, government, and other non-profit Web pages are
acceptable. All submitted links are subject to review by ClinicalTrials.gov.
URL
Definition: complete URL, including http:// or https://
Limit: 3999 characters.

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Description
Definition: title or brief description of the linked page.
Limit: 254 characters.

Available Study Data/Documents
Definition: Study data sets and documents that are being shared. Provide the following
information for each:
Type
Definition: The type of data set or document being shared.
• Individual Participant Data Set
• Study Protocol
• Statistical Analysis Plan
• Informed Consent Form
• Clinical Study Report
• Analytic Code
• Other (specify)

URL
Definition: The Web address used to request or access the data set or document.
Limit: 3999 characters.
Identifier
Definition: The unique identifier used by a data repository for the data set or
document.
Limit: 30 characters.
Comments
Definition: Additional information including the name of the data repository or other
location where the data set or document is available. Provide any additional
explanations about the data set or document and instructions for obtaining access,
particularly if a URL is not provided.
Limit: 1000 characters.

Responsible Party Contact Information § (Provided as part of User Information or
Organization Information in a PRS Account)
Definition: Administrative information to identify and enable communication with the
responsible party by telephone, email, and regular mail or delivery service. Responsible Party
Contact Information is for the individual who is the responsible party or of a designated
employee of the organization that is the responsible party. (Will not be made public - for
administrative purposes only.)

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Note: "Responsible party" means with respect to a clinical study, the sponsor of the
clinical study, as defined in 21 CFR 50.3; or the principal investigator of such clinical
study if so designated by a sponsor, grantee, contractor, or awardee, so long as the
principal investigator is responsible for conducting the study, has access to and control
over the data from the clinical study, has the right to publish the results of the study, and
has the ability to meet all of the requirements for the submission of clinical study
information. For a pediatric postmarket surveillance of a device product that is not a
clinical trial, the responsible party is the entity who FDA orders to conduct the pediatric
postmarket surveillance of the device product.
•

Name of Individual

•

Official Title

•

Physical Address

•

*
*

•

Name of Organizational Affiliation

•

Street Address

•

City

*
• ZIP/Postal Code *
• Country *
Mailing Address * (If different from Physical Address)
• Name of Organizational Affiliation *
• Street Address *
• City *
• State/Province *
• ZIP/Postal Code *
• Country *
• Phone: * Use the format 800-555-5555 within the United States and
•

State/Province

•

Canada. Otherwise, provide the full number, including the country code.
Ext: phone extension, if needed

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•

Email:

* Electronic mail address

History of Changes
2017-01-18: Document updated with data element changes per the FDAAA 801 final rule
(42 CFR Part 11).

File Type	application/pdf
File Modified	2016-12-21
File Created	2016-11-30