Form 1 Registration

Version Date: 08/2023
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OMB Control Number: 0925-XXXX
Expiration Date: XX/XX/XXXX

NCI dbGaP Initial Study Registration Information
In order for the National Cancer Institute to begin registration of your study in the dbGaP Submission System, please complete
this form and the Institutional Certification form and send both to your Genomic Program Administrator (GPA).
Information about the Institutional Certification form is available on the NIH Scientific Data Sharing website: https://
sharing.nih.gov/genomic-data-sharing-policy/institutional-certifications/completing-an-institutional-certification-form
Information about registering and submitting data into dbGaP, including contacts for data submission questions, is available
at the NIH dbGaP Study Submission Guide: https://www.ncbi.nlm.nih.gov/gap/docs/submissionguide/
PART I – PI and PI Assistant/Data Submitter Information
Principal Investigator (PI): Provide the study PI information. This person must have an eRA Commons account to access the
study registration (https://www.era.nih.gov/).
PI Name:

PI Email:

PI Institution:

eRA Commons Username (if available):

PI Assistant/Submitter: If someone other than the PI should be the main point of contact for the study and receive the
invitation to the dbGaP Submission Portal, please provide that contact information here. This person must have an eRA
Commons account to access the study registration (https://www.era.nih.gov/).
PI Assistant/Submitter Name:

PI Assistant/Submitter Email:

PI Assistant/Submitter Institution:

eRA Commons Username (if available):

PART II – dbGaP Study Name and Source of Study Samples
Study Name (this should match the study name on the Institutional Certification form, 255 character limit in the system):

Source(s) of Study Samples – check all that apply:
☐ Clinical trial(s) – check all that apply:
☐ NCI CTEP-supported clinical trial (including trials

☐ Source(s) other than a clinical trial – check all that apply:
☐ NCI-supported study collecting specimens
conducted in the NCTN, ETCTN, or other CTEP networks)
☐ Other NIH-supported study collecting specimens
☐ Other NCI-supported clinical trial
☐ Study not supported or funded by NIH, specify:
☐ NCI Intramural clinical trial
☐ Other NIH-supported clinical trial
☐ Clinical trial not supported or funded by NIH, specify:

For all clinical trials from which specimens and/or data are being used, For all studies from which specimens and/or data are being used,
provide the clinical trial name and the ClinicalTrials.gov NCT number: provide the study name:

Version Date: 08/2023
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OMB Control Number: 0925-XXXX
Expiration Date: XX/XX/XXXX

For all NCI- or NIH-supported clinical trials from which specimens
and/or data are being used, provide the Grant, Contract, and/or
Intramural Project numbers supporting the clinical trials:

For all NCI- or NIH-supported studies from which specimens and/or
data are being used, provide the Grant, Contract, and/or Intramural
Project numbers supporting the studies:

Briefly describe (including relevant grant/contract/project number(s)) any other NCI or NIH support for this study:

PART III – Acknowledgment Statement
Acknowledgment Statement: This is how future users will be expected to acknowledge this dataset in publications once it is
released. Please provide specific points that should be included in the Acknowledgment, such as sources of support or
collaborators who provided subjects or samples. NIH support must be specifically acknowledged by including the grant
number. Consider citing a publication that comprehensively describes the origin of the dataset.
Acknowledgment Statement for this study:

Do you plan to deposit data using dbGaP for this study?
If YES, go to Part IV.
If NO, skip Part IV and go to Part V.

Yes

No

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OMB Control Number: 0925-XXXX
Expiration Date: XX/XX/XXXX

PART IV – Plans for Data Deposition Using dbGaP (Initial Study Data Outline)
Part IV should only be completed if you plan to deposit data using dbGaP for this study. For each category below, indicate
whether you intend to deposit that type of data using dbGaP for this study (Yes or No). If yes, provide any further details
requested within that category.
Subject and Sample IDs: these data will be submitted if any data are being deposited using dbGaP. The answer to this
question will typically be “Yes.”
Do you intend to deposit Subject and Sample IDs in dbGaP?

Yes

No

If “Yes,” identify the sample types that data are expected from (check all that apply):
☐ Germline
☐ Tumor
☐ Normal

☐ DNA
☐ RNA
☐ Mitochondria

☐ Microbiome
☐ From repository
☐ Other, please specify:

Phenotype Data: these datasets include data associated with the subject, including clinical and demographic data, and data
associated with the sample. The answer to this question will typically be “Yes.”
Do you intend to deposit Phenotype Data in dbGaP?

Yes

No

Molecular Data: This does not include raw sequencing data and alignment information, which will be described below under
“Sequence Data.” This does include any GWAS, SNP array, imputations, transcriptomic, epigenomic, gene expression, variant
calls from WGS, WXS, and targeted sequencing data.
Do you intend to deposit Molecular Data in dbGaP?

Yes

No

If “Yes,” identify the molecular data that are expected to be submitted (check all that apply):
☐ Sequence-based multi sample genotype files
☐ Array-based multi sample genotype files
☐ Single sample genotype files derived from

sequencing

☐ Imputed genotypes (IMPUTE, etc.)
☐ Tumor/normal variations / somatic SNV (.MAF)

☐ CNV calls from microarray
☐ Methylation array data or summaries
☐ Expression array data or summaries
☐ CNV calls derived from sequencing
☐ Other, please specify:

Sequence Data: Any high throughput sequence data (WGS, WXS, RNA-Seq, etc.) in BAM, CRAM, FASTQ formats.
Do you intend to deposit Sequence Data and/or Sequence Metadata in dbGaP?

Yes

No

If “Yes,” please indicate how you intend to store the sequence data:
☐ Sequence metadata and sequence data will be stored using NCBI storage for sequence data (most common)
☐ Sequence metadata will be submitted to NCBI, but the sequence data will be stored in a separate NCI cloud

storage location.

If sequence data will be stored in an NCI cloud storage location, please indicate the NCI cloud storage location:
☐ Google Cloud

☐ Amazon Cloud

☐ Other, please specify:

If sequence data will be stored in NCI cloud storage, who is the NCI contact for this cloud storage location?
Cloud Storage Contact Name:

Contact Email:

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OMB Control Number: 0925-XXXX
Expiration Date: XX/XX/XXXX

If Sequence Data and/or Metadata will be deposited, identify the sequencing data expected to be submitted:
☐ Whole or targeted genome
☐ Whole or targeted exome
☐ RNAseq – whole or targeted transcriptome

☐ MethylSeq / Epigemonic Marks
☐ Microbiome sequence (e.g., metagenome, 16S rRNA)
☐ Other, please specify:

Links to Other Study Data in Unrestricted-Access NCBI Databases: (not typical).
Do you intend to link to other study data in unrestricted-access NCBI databases?

Yes

No

If “Yes,” check all that apply:
☐ GEO: repository of high-throughput gene expression data and hybridization arrays, chips, microarrays
☐ SRA: archive of raw sequencing data and alignment information from high-throughput sequencing platforms
☐ GenBank: genetic sequence database comprising an annotated collection of publicly available DNA sequences
☐ Other, please specify:
Association Analysis: Any aggregated genomic level data (not typical).
Do you intend to deposit Association Analysis Data in dbGaP?

Yes

No

If “Yes,” check all that apply:
☐ SNP Based Association Results

☐ Gene Based Association Results

If “Yes,” should the analyses be included in the Compilation of Aggregate Genomic Data (CADA), a collection of
analyses across many dbGaP studies that can be accessed with a single Data Access Request?
Yes
No
Study Documents: Any consent forms, protocols, questionnaires, etc., that correspond to the data (not typical).
Do you intend to deposit Study Documents in dbGaP?

Yes

No

Medical Images: Any scan images, etc. (not typical).
Do you intend to deposit Medical Images in dbGaP?

Yes

No

Other: Any other files not covered above or notes about the expected data (not typical).
Do you intend to deposit other files not covered above?
Yes
No
Is there other information the dbGaP curators should have about the expected data?
PART V – Plans for Data Deposition Using External Data Sources
External Data Source (EDS): A non-dbGaP NIH Institute or Center-Supported Repository that meets core NIH standards for
establishing data quality and data management service protocols for NIH, based on the programmatic need of the NIH
Institute or Center. Studies with data in the EDS will require credentialed users to apply for access to the data through dbGaP
Authorized Access. Use of an External Data Source to deposit data may require prior approval from NCI.
Do you plan to deposit data in an external data source for this study?
If “Yes,” identify the external data source:
Who is the NCI or NIH contact for this external data source?
Contact Name:

Contact Email:

Yes

No