Clinical Research Operations

IRB Submission and Response: New Protocol

Purpose: To identify the steps required to submit a new protocol to the NCI IRB and respond to IRB stipulations.

Step 1:
Action: Create Protocol Files and Folders on the secure server

A. Create a new subfolder in the specified protocol folder in the Principal Investigator’s (PI) folder on the secure Server, titled Institutional Review Board (IRB) Initial

B. Save the following documents in the new subfolder:

• Protocol: <short name> response to SRC stips protocol clean as <short name> Initial Protocol
  date
• Consent: <short name> Initial consent date

Step 2:
Action: Complete the Study Application and the Initial IRB Submission form in iRIS

A. Complete Study Application

• iRIS Users manual available at http://home.ccr.cancer.gov/intra/clin_ops/IRB/ (this link will change when new IRB section is completed)

B. Complete the Initial IRB Submission Form

C. Attach the following required documents to the Initial IRB Submission:

• <short name> Initial Protocol date (pdf)
• <short name> Initial consent date (Word)
• <short name>SRC review and approval date
• Note: Save as a single pdf document to include the SRC minutes, response to SRC memo
  and final approval document

D. Attach the following documents (if applicable):

• Radiation Safety Committee Form 88-23 (a)
• 1572 Form
• Sponsor Approval
• OBA Approval

E. Assign NCI Staff for protocol sign-off

• Required Signatures include: PI, AIs and Branch Chief
• Note: Assigned staff will receive an e-mail notifying them of this action in their Outlook email

F. Obtain Non-NCI Clinical Director’s signature for those AIs from another Institute by adding the name in the iRIS routing list

• OR

Obtain the AI’s Clinical Director’s signature on the title page and upload signed title page into iRIS’ Other Study documents section as pdf document and attach to Initial IRB submission form

G. Submit to IRB within 7 calendar days of SRC approval, or by next IRB Deadline

Step 3:
Action: Complete Other Initial IRB Submission Required Forms

A. Complete and submit the DEC Clearance Submission Form in iRIS (For NCI PIs only)

• Attach the title page of the protocol (with AI list of names) and the Précis into the DEC Clearance Submission form.

B. Complete and submit Prepare Travel Reimbursement form in iRIS

C. Complete and submit Clinical Center’s Prospective Protocol Resource Impact Assessment form (PRIA) See SOP #___

Step 4:
Action: Respond to Initial IRB Submission Stipulations

A. Create a new subfolder in the specified protocol folder Institutional Review Board (IRB) Initial in the PI’s folder on the secure Server, titled Response to IRB Stipulations

B. Draft the response to IRB stipulation for Protocol and Consent documents:

1. Save the document reviewed by the IRB as <short name> resp to IRB stips protocol tracked date
2. Save the consent reviewed by the IRB as <short name> resp to IRB stips consent tracked date.
3. Turn on "Track Changes" in the Word document and make the revisions in response to the stipulations set forth by the IRB review.
4. Contact PI or AI to discuss any items that require their input
5. Contact PI to discuss final response and obtain any additional information
6. Incorporate any outstanding changes at this point (i.e., FDA requests, sponsor changes)
Note: As newer versions of the protocol tracked are created, move old versions to a Drafts folder

C. Enter the explanation of the changes for each stipulation contained in the IRB review in the Review Response form for the submission in iRIS.

D. Create final versions of the response to stipulations documents

E. Quality Check (QC) the “tracked changes” protocol and consent to ensure the changes have been made consistently.

F. QC the changes against the stipulations itemized in iRIS to ensure that all changes are documented.

G. Create final Word file versions of the protocol and consent (clean and tracked), update Table of Contents (TOC) and insert pagination as needed

H. Create pdf versions of the protocol clean and tracked

I. Upload response in iRIS and attach the appropriate documents from the following list:

• Protocol (pdf)
• Consent (Word)
• DEC (if necessary)
• OBA/IBC approvals
• Radiation Safety Committee NIH Form 88-23 (a)
• 1572 Form
• Investigator’s Brochure
• FDA IND Acknowledgement Letter or Sponsor Approval Letter
• Other

J. Review response to stipulations in iRIS for accuracy

• Check AI list against previously submitted DEC, accrual, précis, IND#, etc.

K. Update responses as needed

L. Route through any AIs who have been added or did not sign in iRIS at initial submission.

M. Route through PI for sign-off in iRIS.

Step 5:
Action: IRB Approval

A. Within the "IRB Initial" folder, create a subfolder in the protocol file labeled Approved Documents

B. Save the IRB approval, iRIS notification, and signed 1195 in the IRB folder as <short name> IRB approval memo date

C. Save the OPS watermarked approved consent(s) in the Approved Documents subfolder as <XXCXXXX Consent date>

D. Save a copy of the last final clean Word file version of the protocol in the Approved Documents folder as <XXCXXXX Protocol date>

E. Forward copies of approved documents as needed, i.e. Sponsor, multi-center sites, FDA (see SOP for FDA submissions)

F. Post final approved documents to any Team/Branch specific sites