Instructions for the Principal Investigator 

STEP 1: PROJECT INFORMATION

• All projects (human and non-human) that need compliance with the NIH GDS policy require basic project information.
• Please refer to the CCR GDS website or contact the CCR GPA if you are uncertain whether your project/protocol falls within the purview of the GDS.
• Project information required includes the following:
• Project Title
• Principal Investigator name, email, phone number, title, branch
• For clinical trials, Principle investigator is considered the protocol Principal Investigator of Lead Associate Investigator.  For laboratory-based studies, Principal Investigator is considered the scientist leading the research.
• Specify the organism type (human, non-human, or both)
• Indicate the name/study number of the Parent Protocol/Project
• Parent Protocols/Projects may be Tissue Procurement studies, OHRSP exemptions, or other umbrella projects in which multiple protocols/projects with different investigators are conducted under the umbrella protocol/project.
• Save the Project Information

 STEP 2: ESTABLISHING USER ACCESS

• You have the option of giving other NIH Staff permission to access the Project and the associated forms.
• Go to the User Access Ribbon and click New
• Enter the NIH User Name (which will link to full name and email)
• Access type (Read Only or Read/Write)

 STEP 3: SELECT THE FORMS TO COMPLETE. 

• Human Studies require a Genomic Data Sharing Plan AND Institutional Certification Memo(s).
• Non-Human Studies require a Genomic Data Sharing Plan only.

 STEP 4: GENOMIC DATA SHARING PLAN

• A Genomic Data Sharing Plan can be established by clicking the Genomic Data Sharing Plan Ribbon.
• Click to expand the Ribbon and select NEW to start generating a Genomic Data Sharing Plan.
• Elements of a Genomic Data Sharing Plan include the following:
  • Principal Investigator information
    • This is auto-populated from the Project Information
  • Project/protocol Information
  • Data type
  • Data repository identified for submission
  • Data submission and release timeline
  • Data use limitations
    • These reflect any data use limitations specified in the consent. There are four main categories:
      • General Research Use-Data can be used for any research purpose;
      • Health/Medical/Biomedical-Data use is limited to a focus on health/medical/biomedical research objectives, excluding the study of population origins or ancestry;
      • Disease-Specific-Data can be used only for research on a specific disease or related condition; and,
      • Other-Specify other criteria
• Genomic Data Sharing Plan Review and Approval
  • The GPA will review and approve the Genomic Data Sharing Plan
  • For plans that require revision, the plan will be returned to the investigator with instructions from the GPA of the needed modifications. 
    • Once the revisions have been made, resubmit the Genomic Data Sharing Plan for review and approval by the GPA.
  • The submitter will be notified of GPA approval via an email generated from the submission system.
• Scientific Director Review and Approval
  • GPA will submit the GPA approved CCR Genomic Data Sharing Plan to the CCR Scientific Director for review and approval.
  • Approval by the Scientific Director completes the Genomic Data Sharing Plan submission and approval process.  The submitter will be notified, via email, of approval by Scientific Director.
  • For clinical studies, all completed Genomic Data Sharing Plans will be available to the Protocol Support Office (PSO) staff. The PSO will upload a copy of completed Genomic Data Sharing Plan to the appropriate protocol specific regulatory file.
  • For Plans not approved by the Scientific Director:
    • GPA will work with the investigator to fulfill the requirements of the CCR Genomic Data Sharing Plan. 
    • Once a revised CCR Genomic Data Sharing Plan is in place, the revised plan will require resubmission for approvals.
      • Once approved, at any point you wish to generate the Genomic Data Sharing Plan, select Export.

 STEP 5: INSTITUTIONAL CERTIFICATION MEMO(S)

• An Institutional Certification Memo is established by clicking the Institutional Certification Ribbon.

• Note: more than one Institutional Certification Memo is required if the research began prior to August 31, 2015 (with or without consent) and continued past the policy implementation date when consent is mandatory. One memo is required for each instance:

1) prior to August 31, 2015 with consent

2) prior to August 31, 2015 without consent

3) after August 31, 2015 with consent

• Only ONE Institutional Certification Memo can be generated at one time.  If your project requires most than one memo, you will need to repeat the procedures described below for EACH instance requiring an Institutional Certification Memo.
• Click to expand the ribbon and select NEW to start generating an Institutional Certification Memo.
  • A pop-up box will open
    • Indicate if the samples have been collected before August 31, 2015 (Yes/No)
    • Indicate if the samples were collected with or without consent (Yes/No)
• Complete the header information that is not already pre-populated from the Project Information
  • NOTE: This portal may be used by other NIH Institutes so not all information provided is prepopulated for NCI.
    • Name of Institution
      • NCI
    • Organization of GPA
      • NCI
    • Organization of SD (Scientific Directors)
      • NCI
    • Original Study Name
    • Project Title for Data to be submitted will be auto-populated from the Project Information page.
    • Select data access, unrestricted or controlled access
      • Human studies are mostly controlled access
    • If the release of Genomic Summary Results (GSR) was determined to be sensitive by the GSR committee, check the controlled-access box.
      • A text box will open and please provide an explanation justifying why this population meets the sensitive criteria.
      • NOTE: The GSR are available through unrestricted access except when a population is determined to meet sensitive criteria.
        • Sensitivity is defined as study populations from isolated geographic regions, or with rare or potentially stigmatizing traits which could result in increased privacy or confidentiality risks.
  • Add consent groups for each research site
    • Select ADD
    • Research site name (one research site per row)
    • Select Data Use Limitations
      • Data Use Limitations are based on the terms of the informed consent of the study participants from whom the genomic data have been generated.
      • Click the ? to open definitions for each option.
    • Data Use Limitation Modifiers
      • These modifiers are also based on the consent.
      • Click the ? to open definitions for each option if applicable.
  • Select action
    • Save-enables you to return at a later time and edit content
    • Submit-circulates the memo for review and approval/signature
    • Cancel-All content entered will be withdrawn
  • NOTE: You may have to complete more than one Institutional Certification Memo
    • Once the revisions have been made, resubmit the Institutional Certification Memo for review and approval by the GPA.
  • The submitter will be notified of GPA approval via an email generated from the submission system.

• Institutional Memo Approval
• Submitted Institutional Certification Memo’s are first routed to the GPA.
• GPA Review and Approval
  • Approval by the memo by the GPA routes the memo to the Scientific Director for review and approval.
  •  Memo’s that require revision will be returned to the investigator with instructions from the GPA of the needed modifications.
    • Once the revisions have been made, resubmit the Institutional Certification Memo for approval by the GPA.
  • The submitter will be notified of GPA approval via an email generated from the submission system.
• Scientific Director Review and Approval
  • GPA will submit the GPA approved Institutional Certification Memo to the CCR Scientific Director for review and approval.
  • Approval by the Scientific Director completes the Institutional Certification Memo submission and approval process. 
  • The submitter will be notified, via email, of approval by Scientific Director.
  • For Institutional Certification Memo’s not approved by the Scientific Director:
    • GPA will work with the investigator to fulfill the requirements of the Institutional Certification Memo. 
    • Once a revised Institutional Certification memo is in place, the revised plan will require resubmission for approvals.
      • Once approved, at any point you wish to generate the PDF memo, select Export.

Instructions for the Scientific Director

Reviewing a submitted Genomic Data Sharing Plan (GDSP) 

1. You will receive an email alert once a GDSP has been reviewed and approved by the GPA and routed to you for your review.
2. Log in to the Genomic Data Sharing portal using your NED credentials.
3. Successful log in should take you to your landing page within the submission portal. The page is divided into four sections, (a) GDSPs awaiting SD approval (b) GDSPs reviewed by SD (c) IC memo's awaiting SD approval and (d) IC memo's reviewed by the SD. See figures a and c below for examples.
4. Click the "View" button to view the details of the GDSP.
5. Once you have completed your review, add any comments you may wish to add (adding comments is not mandatory but encouraged). Based on your review click the "APPROVE" or "REJECT" button. See figure b below for a screen-shot of the SD review section.

Reviewing a submitted Institutional Certification (IC) Memo

1. 1. You will receive an email alert once an IC memo has been reviewed and approved by the GPA and routed to you for your review.
   2. Log in to the Genomic Data Sharing portal using your NED credentials.
   3. Successful log in should take you to your landing page within the submission portal. The page is divided into four sections, (a) GDSPs awaiting SD approval (b) GDSPs reviewed by SD (c) IC memo's awaiting SD approval and (d) IC memo's reviewed by the SD. 
   4. Click the "View" button to view the details of the IC.
   5. Once you have completed your review, add any comments you may wish to add (adding comments is not mandatory but encouraged). Based on your review click the "APPROVE" or "REJECT" button. See figure b below for a screen-shot of the SD review section.