ClinicalTrials.gov Protocol Data Element Definitions

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ClinicalTrials.gov Protocol Data Element Definitions
(DRAFT)
September 2014

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Required by ClinicalTrials.gov

Required to comply with Food and Drug Administration Amendments Act
(FDAAA), Section 801
(FDAAA) May be required to comply with FDAAA, Section 801
FDAAA

1. Study Identification
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FDAAA
Organization's Unique Protocol ID
Definition: Unique identification assigned to the protocol by the sponsoring organization,
usually an accession number or a variation of a grant number. Multiple studies conducted
under the same grant must each have a unique number.
(Limit: 30 characters)
Examples:
ABT-1233-RV
Merck-023
ACTG 021

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Brief Title FDAAA
Definition: Protocol title intended for the lay public. (Limit: 300 characters)
Example: Safety Study of Recombinant Vaccinia Virus Vaccine to Treat Prostate Cancer
Acronym
Definition: Acronym or initials used to identify this study, if applicable. Enter only the
acronym. If supplied, the acronym is automatically displayed in parentheses following
the brief title. (Limit: 14 characters)
Example:
Brief Title: Women's Health Initiative
Acronym: WHI
Displayed on ClinicalTrials.gov as: Women's Health Initiative (WHI)
Official Title
Definition: Official name of the protocol provided by the study principal investigator or
sponsor.
Example: Phase 1 Study of Recombinant Vaccinia Virus That Expresses Prostate
Specific Antigen in Metastatic Adenocarcinoma of the Prostate (Limit: 600 characters)
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Secondary IDs FDAAA
Definition: Other identification numbers assigned to the protocol, including unique
identifiers from other registries and NIH grant numbers, if applicable. (Limit: 30
characters)
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ID Type Select one. Provide additional information, depending upon selected ID
Type, as noted below. (Limit: 119 characters)
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US 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,
if applicable) are optional.
Examples: R01DA013131, U01HL066582, 5R01HL123451-01A2
Other Grant/Funding Number - also provide name of grantor.
Registry Identifier - also provide name of clinical trials registry.
EudraCT Number - from European Union Drug Regulatory Authorities
Clinical Trial System.
Other Identifier - also provide brief description (i.e., what organization
issued the ID).

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FDAAA
Study Type
Definition: Nature of the investigation. Select one.

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Interventional: studies in human beings in which individuals are assigned by an
investigator based on a protocol to receive specific interventions. Subjects may
receive diagnostic, therapeutic or other types of interventions. The assignment of
the intervention may or may not be random. The individuals are then followed
and biomedical and/or health outcomes are assessed.

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Observational: studies in human beings in which biomedical and/or health
outcomes are assessed in pre-defined groups of individuals. Subjects in the study
may receive diagnostic, therapeutic, or other interventions, but the investigator
does not assign specific interventions to the subjects of the study.


Patient Registry
Definition: For observational studies only, check the Patient Registry box
if this record describes a study that is also considered to be a Patient
Registry. This type of study should only be registered once in the PRS, by
the sponsor responsible for the primary data collection and analysis.
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, health care
services, and/or procedures) and that serves a predetermined scientific,

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clinical, or policy purpose. Patient registries may be single purpose or ongoing data collection programs that address one or more questions.

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Expanded Access: records describing the procedure for obtaining an experimental
drug or device for patients who are not adequately treated by existing therapy,
who do not meet the eligibility criteria for enrollment, or who are otherwise
unable to participate in a controlled clinical study. Expanded Access records are
used to register all types of non-protocol access to experimental treatments,
including protocol exception, single-patient IND, treatment IND, compassionate
use, emergency use, continued access and parallel track.

2. Study Status
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FDAAA
Record Verification Date
Definition: Date the protocol information was last verified. Verification date is shown
along with organization name on ClinicalTrials.gov to indicate to the public whether the
information is being kept current, particularly recruiting status and contact information.
Update verification date when reviewing the record for accuracy and completeness,
even if no other changes are made.

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FDAAA [Required when Study Type is "Interventional" or
Overall Recruitment Status
"Observational".]
Definition: Overall accrual activity for the protocol. Select one.

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Not yet recruiting: participants are not yet being recruited
Recruiting: participants are currently being recruited
Enrolling by invitation: participants are being (or will be) selected from a
predetermined population
Active, not recruiting: study is ongoing (i.e., patients are being treated or
examined), but participants are not currently being recruited or enrolled
Completed: the study has concluded normally; participants are no longer being
examined or treated (i.e., last patient's last visit has occurred)
Suspended: recruiting or enrolling participants has halted prematurely but
potentially will resume
Terminated: recruiting or enrolling participants has halted prematurely and will
not resume; participants are no longer being examined or treated
Withdrawn: study halted prematurely, prior to enrollment of first participant

NOTE: Contact information is shown on ClinicalTrials.gov only when overall status is
"Recruiting" or "Not yet recruiting".

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Why Study Stopped?
Definition: For suspended, terminated or withdrawn studies, provide a brief explanation
of why the study has been halted or terminated. If desired, use brief summary or detailed
description to provide additional information. (Limit: 160 characters)
Study Start Date FDAAA
Definition: Date that enrollment to the protocol begins.

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Primary Completion Date FDAAA [ Required by ClinicalTrials.gov for records first
released on or after December 1, 2012]
Definition: As specified in US Public Law 110-85, Title VIII, Section 801, with respect
to an applicable clinical trial, the date that the final subject was examined or received an
intervention for the purposes of final collection of data for the primary outcome, whether
the clinical trial concluded according to the prespecified protocol or was terminated. A
"Type" menu is also included, with options Anticipated and Actual. For active studies, set
Type to Anticipated and specify the expected completion date, updating the date as
needed over the course of the study. Upon study completion, change Type to Actual and
update the date if necessary.
Study Completion Date
Definition: Final date on which data was (or is expected to be) collected. Use the Type
menu (Anticipated/Actual) as described above.

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Expanded Access Status
Definition: Status indicating availability of an experimental drug or device outside any
clinical trial protocol. This data element is only applicable for Expanded Access records
(see Expanded Access under Study Type). Select one.
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Available: expanded access is currently available for this treatment.
No longer available: expanded access was available for this treatment previously
but is not currently available and will not be available in the future.
Temporarily not available: expanded access is not currently available for this
treatment, but is expected to be available in the future.
Approved for marketing: this treatment has been approved for sale to the public.

3. Sponsor/Collaborators
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Sponsor FDAAA
Definition: Name of primary organization that oversees implementation of study and is
responsible for data analysis. For applicable clinical trials, sponsor is defined in 21 CFR
50.3. (Limit: 160 characters)
Examples: National Institute of Allergy and Infectious Diseases, Bristol-Myers Squibb

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Responsible Party FDAAA [ Required by ClinicalTrials.gov for records first released on
or after December 1, 2012]
Definition: As defined in US Public Law 110-85, Title VIII, Section 801, the term
"responsible party," with respect to a clinical trial, means
1. the sponsor of the clinical trial (as defined in 21 CFR 50.3) or
2. the principal investigator of such clinical trial if so designated by a sponsor,
grantee, contractor, or awardee, so long as the principal investigator is responsible
for conducting the trial, has access to and control over the data from the clinical
trial, has the right to publish the results of the trial, and has the ability to meet all
of the requirements for the submission of clinical trial information.

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Select one:
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Sponsor: the entity (e.g., corporation or agency) that initiates the study
Principal Investigator: the individual who serves as the principal
investigator and is designated as responsible party, consistent with the
conditions described in the statute
 Sponsor-Investigator: the individual who both initiates and conducts the
study
Investigator Information
If either Principal Investigator or Sponsor-Investigator is selected, the
following is required:
 Investigator Name: select from the list of PRS users/administrators; if the
investigator does not have an account, one must be created. The Full
Name for the selected PRS account must be the name of a person and
include first and last name, and may include any relevant degrees.
 Investigator Official Title: title of the investigator, at the primary
organizational affiliation (Limit: 254 characters)
 Investigator Affiliation: primary organizational affiliation of the
investigator; typically will be the same as sponsor's full name, as recorded
in the PRS (Limit: 160 characters)

Collaborators
Definition: Other organizations (if any) providing support, including funding, design,
implementation, data analysis and reporting. The data provider is responsible for
confirming all collaborators before listing them. Provide up to 10 full names of
collaborating organizations. (Limit: 160 characters per name)
4. Oversight
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FDA Regulated Intervention? (FDAAA)
Definition: Indicate whether this trial includes an intervention subject to US Food and
Drug Administration regulation under section 351 of the Public Health Service Act or
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any of the following sections of the Federal Food, Drug and Cosmetic Act: 505, 510(k),
515, 520(m), and 522. Select Yes/No.
o Section 801 Clinical Trial? (FDAAA)
Definition: If this trial includes an FDA regulated intervention, indicate whether
this is an "applicable clinical trial" as defined in US Public Law 110-85, Title
VIII, Section 801. Briefly, applicable drug trials include controlled clinical
investigations, other than Phase I investigations, of a drug or biologic subject to
US FDA regulation. Applicable device clinical trials are controlled trials with
health outcomes of devices subject to FDA regulation, other than small feasibility
studies, and pediatric postmarket surveillance. Select Yes/No.
 Delayed Posting? (FDAAA)
Definition: If this is a Section 801 applicable clinical trial, indicate
whether this trial includes a device NOT previously approved or cleared
by the US FDA for any use, as specified in US Public Law 110-85, Title
VIII, Section 801. Select Yes/No. If "Yes" is selected, full posting of the
trial information on ClinicalTrials.gov will be delayed until after the
device has been approved or cleared. At that time, it is the registrant's
responsibility to change this selection to "No" and release the record
for full publication.
Investigational New Drug Application (IND)/Investigational Device Exemption
(IDE) Information: Complete the following only if the protocol involves an
Investigational New Drug Application (IND) or Investigational Device Exemption (IDE)
under US Food and Drug Administration regulations.
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(FDAAA)
IND/IDE Protocol?
Definition: Indicate if the protocol involves an Investigational New Drug
Application (IND) or Investigational Device Exemption (IDE) under US Food
and Drug Administration regulations (Will not be made public - for administrative
purposes only.)

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(FDAAA)
IND/IDE Grantor
Definition: FDA center to which the IND or IDE was submitted, i.e.,
Center for Drug Evaluation and Research (CDER) or Center for Biologics
Evaluation and Research (CBER) for INDs; Center for Devices and
Radiological Health (CDRH) for IDEs. Select one. (Will not be made
public - for administrative purposes only.)

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(FDAAA)
IND/IDE Number
Definition: Number assigned to an Investigational New Drug Application
(IND) or Investigational Device Exemption (IDE). (Will not be made
public - for administrative purposes only.)
Examples: 22,333; BB1234

IND/IDE Serial Number (FDAAA)
Definition: Use the serial number from the first submission of the protocol

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to the IND or IDE. (Will not be made public - for administrative purposes
only.)
Has Expanded Access? FDAAA
Definition: Indicate whether any non-protocol access is to be provided for
the investigational drug or device. If so, an Expanded Access record
should also be created for this IND/IDE.
Expanded Access Record FDAAA
Definition: The ClinicalTrials.gov identifier (NCT number) for the
Expanded Access record associated with this study, specified if and only if
"Yes" is specified for Has Expanded Access.
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Human Subjects Review Submitted studies must have approval from a human subjects
review board prior to the recruitment of the first patient. Appropriate review boards
include an Institutional Review Board, an ethics committee or an equivalent group that is
responsible for review and monitoring of this protocol to protect the rights and welfare of
human research subjects. A study may be submitted for registration prior to approval of
the review board so long as the study is not yet recruiting patients.
Review board information is desired but not required for trials associated with U.S. FDA
Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications.
Review board information is required for internal administrative use and is not revealed
to the public.

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Board Approval
- provide information for only one review board, even for studies
involving multiple boards
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Board Approval Status
Definition: Human subjects review board approval status. Select one.
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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
Submitted, exempt: review board has granted an exemption in response to
the approval request
Submitted, denied: review board has denied the approval request
Submission not required: the study does not require human subjects
review

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Board Approval Number
(required only if status is "Submitted, approved")
Definition: Number assigned by the human subjects review board upon approval
of the protocol. May be ommitted if status is anything other than approved. If the
human subjects review board does not assign numbers, please enter the date of
approval in mm/dd/yyyy format.

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Board Name
(required unless status is "Submission not required")
Definition: Full name of the approving human subjects review board.
Example: National Institutes of Health - NCI - IRB #1

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Board Affiliation
(required only if status is "Submitted, approved" or
"Submitted, exempt")
Definition: Official name of organizational affiliation of the approving human
subjects review board. (Limit: 255 characters)
Example: US National Institutes of Health

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Board Contact
(required only if status is "Submitted, approved" or
"Submitted, exempt")
Definition: Contact information for the human subjects review board.

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Phone (or Email required):
Use the format 123-456-7890 within the
United States and Canada. Otherwise, provide the country code.
Ext: Phone extension, if needed

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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.

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Oversight authority information is displayed on ClinicalTrials.gov. For IND/IDE
protocols, Oversight Authority is filled in automatically with "United States: Food and
Drug Administration."
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Oversight Authorities
Definition: The name of each national or international health organization with
authority over the protocol. Use the following format for each authority:
country: organization name
Examples:
United States: Institutional Review Board
United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Australia: Therapeutic Goods Administration

5. Study Description
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FDAAA
Brief Summary
Definition: Short description of the protocol intended for the lay public. Include a brief
statement of the study hypothesis. (Limit: 5000 characters)

Example: The purpose of this study is to determine whether prednisone, methotrexate,
and cyclophosphamide are effective in the treatment of rapidly progressive hearing loss
in both ears due to autoimmune inner ear disease (AIED).
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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 (1) registry procedures and (2) other
quality factors (e.g., 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:
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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
(e.g., medical records, paper or electronic case report forms, or interactive voice
response systems).
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Data dictionary that contains detailed descriptions of each variable used by the
registry, including the source of the variable, coding information if used (e.g.,
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
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
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FDAAA
Conditions or Focus of Study
Definition: Primary disease or condition being studied, or focus of the study. Diseases or
conditions should use the National Library of Medicine's Medical Subject Headings
(MeSH) controlled vocabulary when possible.

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
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(FDAAA)
Interventional Study Design
Definition: Primary investigative techniques used in the protocol. Select the most
appropriate term describing the protocol from each of the following data elements.

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Primary Purpose FDAAA - reason for the protocol
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Treatment: protocol designed to evaluate one or more interventions for
treating a disease, syndrome or condition
Prevention: protocol designed to assess one or more interventions aimed at
preventing the development of a specific disease or health condition
Diagnostic: protocol designed to evaluate one or more interventions aimed
at identifying a disease or health condition
Supportive Care: protocol designed to evaluate one or more interventions
where the primary intent is to maximize comfort, minimize side effects or
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mitigate against a decline in the subject's health or function. In general,
supportive care interventions are not intended to cure a disease.
Screening: protocol designed to assess or examine methods of 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: protocol designed to evaluate the delivery,
processes, management, organization or financing of health care.
Basic Science: protocol designed to examine the basic mechanism of
action (e.g., physiology, biomechanics) of an intervention.
Other: describe in Detailed Description.

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FDAAA
Study Phase
Definition: Phase of investigation, as defined by the US FDA for trials involving
investigational new drugs. Use "N/A" for trials that do not involve drug or
biologic products. Select only one.
 N/A: for trials without phases (e.g., trials of devices or behavioral
interventions)

Phase 0: exploratory trials, involving very limited human exposure, with
no therapeutic or diagnostic intent (e.g., screening studies, microdose
studies). See FDA guidance on exploratory IND studies for more
information.
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: for 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
patients with the disease or condition under study and to determine the
common short-term side effects and risks
Phase 2/Phase 3: for trials that are a combination of phases 2 and 3
Phase 3: includes expanded controlled and uncontrolled trials 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 and provide an adequate basis
for physician labeling

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Phase 4: studies of FDA-approved drugs to delineate additional
information including the drug's risks, benefits, and optimal use
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Intervention Model (FDAAA) (at least one of the following required: Intervention
Model, Masking, Allocation. All may be required as part of Study Design under
PL 110-85, Section 801) - intervention assignments
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Single Group: single arm study
Parallel: participants are assigned to one of two or more groups in parallel
for the duration of the study
Cross-over: participants receive one of two alternative interventions
during the initial phase of the study and receive the other intervention
during the second phase of the study
Factorial: two or more interventions, each alone and in combination, are
evaluated in parallel against a control group

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Number of Arms (FDAAA)
Definition: Number of intervention groups (enter 1 for single-arm study).

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Masking (FDAAA) (at least one of the following required: Intervention Model,
Masking, Allocation. All may be required as part of Study Design under PL 11085, Section 801) - knowledge of intervention assignments
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Open: no masking is used. All involved know the identity of the
intervention assignment.
Single Blind: one party, either the investigator or participant, is unaware
of the intervention assignment; also called single-masked study.
Double Blind: two or more parties are unaware of the intervention
assignment
If Single Blind or Double Blind is selected, check the role(s) that are to be
masked: Subject, Caregiver, Investigator or Outcomes Assessor.

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Allocation (FDAAA) (at least one of the following required: Intervention Model,
Masking, Allocation. All may be required as part of Study Design under PL 11085, Section 801) - participant assignment to intervention group
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N/A: single arm study
Randomized Controlled Trial: participants are assigned to intervention
groups by chance
Nonrandomized Trial: participants are expressly assigned to intervention
groups through a non-random method, such as physician choice

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Study Classification (formerly Endpoint) - type of primary outcome or endpoint
that the protocol is designed to evaluate. Select one.
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N/A: not applicable
Safety: show if the drug is safe under conditions of proposed use
Efficacy: measure of an intervention's influence on a disease or health
condition
Safety/Efficacy
Bio-equivalence: scientific basis for comparing generic and brand name
drugs
Bio-availability: rate and extent to which a drug is absorbed or otherwise
available to the treatment site in the body
Pharmacokinetics: the action of a drug in the body over a period of time
including the process of absorption, distribution and localization in tissue,
biotransformation, and excretion of the compound
Pharmacodynamics: action of drugs in living systems
Pharmacokinetics/dynamics

Enrollment (Target or Actual Number of Subjects) FDAAA
Definition: Number of subjects in the trial. A "Type" menu is also included, with
options Anticipated and Actual. For active studies, set Type to Anticipated and
specify the expected enrollment, updating the number as needed over the course
of the study. Upon study completion, change Type to Actual and update the
enrollment if necessary.

Observational Study Design
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Observational Study Model
follow-up. Select one.
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* - primary strategy for subject identification and

Cohort: group of individuals, initially defined and composed, with
common characteristics (e.g., condition, birth year), who are examined or
traced over a given time period
Case-control: group of individuals with specific characteristics (e.g.,
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 (i.e., control period)
Ecologic or community studies: geographically defined populations, such
as countries or regions within a country, compared on a variety of

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Time Perspective
- temporal relationship of observation period to time of
subject enrollment. Select one.
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environmental (e.g., air pollution intensity, hours of sunlight) and/or
global measures not reducible to individual level characteristics (e.g.,
health care 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

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 - select one
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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)

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

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Enrollment (Target or Actual Number of Subjects)
Definition: Number of subjects in the trial. A "Type" menu is also included, with
options Anticipated and Actual. For active studies, set Type to Anticipated and
specify the expected enrollment, updating the number as needed over the course
of the study. Upon study completion, change Type to Actual and update the
enrollment if necessary.

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*

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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).

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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.

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8. Arms, Groups and Interventions
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Arms: For interventional studies specify the arms, corresponding to Number of Arms
specified under Study Design (for single-arm studies, the following data elements are
optional).

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(FDAAA) - the short name used to identify the arm. (Limit: 62
Arm Label
characters)
Examples:
 Metformin
 Lifestyle counseling
 Sugar pill

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Arm Type
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(FDAAA)

- select one

Experimental
Active Comparator
Placebo Comparator
Sham Comparator
No intervention
Other

Arm Description (FDAAA) - brief description of the arm. This element may not be
necessary if the associated intervention descriptions contain sufficient information
to describe the arm. (Limit: 999 characters)

Groups: For observational studies specify the predefined participant groups (cohorts) to
be studied, corresponding to Number of Groups specified under Study Design (for singlegroup 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).
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Group/Cohort Label
characters)
Examples:
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* - the short name used to identify the group. (Limit: 62

Statin dose titration
Chronic kidney disease, no anemia
No treatment

Group/Cohort Description Definition: Explanation of the nature of the study
group (e.g., those with a condition and those without a condition; those with an
exposure and those without an exposure). Note that the overall study population
should be described under Eligibility. (Limit: 1000 characters)

Interventions: For all studies, and for expanded access records, specify the associated
intervention(s). For interventional studies, at least one intervention must be specified. For
observational studies, specify the intervention(s)/exposure(s) of interest, if any.
o

Intervention Type










o

*

FDAAA

- select one per intervention

Drug (including placebo)
Device (including sham)
Biological/Vaccine
Procedure/Surgery
Radiation
Behavioral (e.g., Psychotherapy, Lifestyle Counseling)
Genetic (including gene transfer, stem cell and recombinant DNA)
Dietary Supplement (e.g., vitamins, minerals)
Other

*

FDAAA - for drugs use generic name; for other types of
Intervention Name
interventions provide a brief descriptive name. (Limit: 200 characters)

For investigational new drugs that do not yet have a generic name, a chemical
name, company code or serial number may be used on a temporary basis. As soon
as the generic name has been established, update the associated protocol records
accordingly.
For non-drug intervention types, provide an intervention name with sufficient
detail so that it can be distinguished from other similar interventions.


Other Names - list other names used to identify the intervention, past or
present (e.g., brand name for a drug). These names will be used to

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improve search results in ClinicalTrials.gov. (Limit: 200 characters per
name)

o



Intervention Description (FDAAA) - cover key details of the intervention. Must be
sufficiently detailed to distinguish between arms of a study (e.g., comparison of
different dosages of drug) and/or among similar interventions (e.g., comparison of
multiple implantable cardiac defibrillators). For example, interventions involving
drugs may include dosage form, dosage, frequency and duration. (Limit: 1000
characters)
Example:
50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Number
of Cycles: until progression or unacceptable toxicity develops.

*

(FDAAA) - if multiple Arms/Groups
[Arm or Group]/Intervention Cross-Reference
have been specified for the study, edit the Cross-Reference, checking boxes to indicate
which of the Interventions are to be administered under each Arm/Group of the study.

9. Outcome Measures


NOTE: When Results are added to a record, outcome measures are transferred from the
protocol section to the results section.



Primary Outcome Measure FDAAA [ Required by ClinicalTrials.gov for records first
released on or after December 1, 2012]
Definition: Specific key measurement(s) or observation(s) used to measure the effect of
experimental variables in a study, or for observational studies, to describe patterns of
diseases or traits or associations with exposures, risk factors or treatment.

*

*

o

Title - A concise name for the specific measure that will be used to determine
the effect of the intervention(s) or, for observational studies, related to core
objectives of the study and receiving the most emphasis in assessment. (Limit:
254 characters)

o

Time Frame (FDAAA) [ Required by ClinicalTrials.gov for records first released
on or after December 1, 2012] - Time point(s) at which outcome measure is
assessed. (Limit: 254 characters)
Description - Additional information about the outcome measure, if needed for
clarification. (Limit: 999 characters)
Safety Issue? (FDAAA) - Is this outcome measure assessing a safety issue? Select:
Yes/No

o
o

*

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Examples:
o

Title: all cause mortality
Time Frame: one year
Safety Issue: No
Title: Evidence of clinically definite ischemic stroke (focal neurological deficits
persisting for more than 24 hours) confirmed by non-investigational CT or MRI
Time Frame: within the first 30 days (plus or minus 3 days) after surgery
Safety Issue: Yes



Secondary Outcome Measures FDAAA
Definition: Secondary measurements that will be used to evaluate the intervention(s) or,
for observational studies, that are a focus of the study. Specify Title, Time Frame,
Description (if needed) and Safety Issue as described above.



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.
Specify Title, Time Frame, Description (if needed) and Safety Issue.

10. Eligibility


*

Gender FDAAA
Definition: Physical gender of individuals who may participate in the protocol. Select
one.






Both: both female and male participants are being studied
Female: only female participants are being studied
Male: only male participants are being studied

Age Limits


*

FDAAA

Minimum Age
Definition: Minimum age of participants. Provide a number and select a unit of
time (years, months, weeks, days, hours or minutes). Select "N/A (No limit)" if no
minimum age is indicated.
Maximum Age
Definition: Maximum age of participants. Provide a number and a unit of time

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(years, months, weeks, days, hours or minutes). Select "N/A (No limit)" if no
maximum age is indicated.


Accepts Healthy Volunteers? FDAAA
Definition: Indicate if persons who have not had the condition(s) being studied or
otherwise related conditions or symptoms, as specified in the eligibility requirements,
may participate in the study. Select Yes/No.



FDAAA
Eligibility Criteria
Definition: Summary criteria for participant selection. The preferred format includes lists
of inclusion and exclusion criteria as shown below. (Limit: 15,000 characters)
Example:

*



Inclusion Criteria:
 - Clinical diagnosis of Alzheimer's Disease
 - Must be able to swallow tablets


Exclusion Criteria:
 - Insulin dependent diabetes
 - Thyroid disease

*



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



Sampling Method
Description.




* - For observational studies only, select one and explain in Detailed

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 patient 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


Multiple locations may be specified. Location is composed of the following fields.

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1 June 2015

*

(FDAAA) (or Facility Contact required)
Central Contact
Definition: Person providing centralized, coordinated recruitment information for the
entire study.




First Name
Middle Initial



Last Name
Degree




*

(FDAAA)

*



Phone (FDAAA): Toll free phone number of the central contact. person. Use the
format 800-555-5555 within the United States and Canada. Otherwise, provide
the country code.
Ext: phone extension, if needed



Email

*

(FDAAA):

electronic mail address of the central contact person



Central Contact Backup
Person to contact if Central Contact is not available.



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





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
Director/Study Principal Investigator).

Facility

*

(FDAAA)



Name: Full name of the organization where the protocol is being conducted.
(Limit: 254 characters)
Examples: UCLA Eye Institute; Springfield Memorial Hospital



City

*

(FDAAA)

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1 June 2015



State/Province
Postal Code



Country

*









(FDAAA)

(FDAAA)

*

Recruitment Status




*

FDAAA

- protocol accrual activity at a facility. Select one.

Not yet recruiting: participants are not yet being recruited
Recruiting: participants are currently being recruited
Enrolling by invitation: participants are being (or will be) selected from a
predetermined population
Active, not recruiting: study is ongoing (i.e., patients are being treated or
examined), but participants are not currently being recruited or enrolled
Completed: the study has concluded normally; participants are no longer being
examined or treated (i.e., last patient's last visit has occurred)
Suspended: recruiting or enrolling participants has halted prematurely but
potentially will resume
Terminated: recruiting or enrolling participants has halted prematurely and will
not resume; participants are no longer being examined or treated
Withdrawn: study halted prematurely, prior to enrollment of first participant

NOTE: Contact information is shown on ClinicalTrials.gov only for locations with status
set to "Recruiting" or "Not yet recruiting".
Tip: When a trial's overall status changes to "Active, not recruiting," it is not necessary to
change recruitment status for each location. Location recruitment status is only shown on
ClinicalTrials.gov when Overall Status is "Recruiting".
Facility Contact

*

(FDAAA)




First Name
Middle Initial



Last Name
Degree






*

(or Central Contact required)

(FDAAA)

*

Phone (FDAAA): (or Email required) office phone of the facility contact person.
Use the format 123-456-7890 within the United States and Canada. Otherwise,
provide the country code.
Ext: phone extension, if needed

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



1 June 2015

*

(FDAAA): (or Phone required) electronic mail address of the facility
Email
contact person

Facility Contact Backup
Person to contact if Facility Contact is not available (i.e., a second contact person).
Investigators (at the protocol location)






First Name
Middle Initial
Last Name
Degree
Role: Site Principal Investigator or Site Sub-Investigator (pick one)

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.
o

PubMed Identifier
Definition: PubMed Unique Identifier (PMID) for the citation in MEDLINE
Example: 10987815

o

Citation
Definition: bibliographic reference in NLM's MEDLINE format (Limit: 2000
characters)
Example: Barza M; Pavan PR; Doft BH; Wisniewski SR; Wilson LA; Han DP;
Kelsey SF. Evaluation of microbiological diagnostic techniques in postoperative
endophthalmitis in the Endophthalmitis Vitrectomy Study. Arch Ophthalmol 1997
Sep;115(9):1142-50

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1 June 2015

Results Reference?
Definition: Indicate if the reference provided reports on results from this clinical
research 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.
o

URL
Definition: complete URL, including http:// (Limit: 254 characters)
Example: http://www.alzheimers.org/
Description
Definition: title or brief description of the linked page. If the page being linked is
the protocol's home page on the sponsor's Web site, include the words "Click here
for more information about this study:" and provide the name of the protocol.
(Limit: 254 characters)
Examples:


Click here for more information about this study: Clinical Trial of Eye
Prophylaxis in the Newborn
The Alzheimer's Disease Education and Referral (ADEAR) Center is a
service of the National Institute on Aging

23