Instructions for WIRB Submissions (UPDATED March 1, 2005)

 

As of February 15, 2005, industry-sponsored, multi-centered clinical trials that have an IND or IDE held by the industry sponsor may be submitted to the Western Institutional Review Board (WIRB) for review ( http://www.wirb.com ).  This includes both initial review of newly submitted protocols and continuing review for protocols currently at the WIRB.

 

It is important for the CUMC IRB, Grants and Contracts, and the Clinical Trial office to be notified of all submissions to the WIRB.  The University must track this information for research compliance and safety of research subjects.  Therefore,  the procedures below should be followed:

 

PRIOR TO SUBMISSION TO THE WIRB

1.         For each protocol, create a new (abbreviated) RASCAL submission that includes:

o       the Proposal (Grants and Contracts) module

o       the Protocol (IRB) module

 

There is no change in the process of completing the Proposal (Grants and Contract) module in RASCAL and submitting the proposal materials to the Clinical Trials Office, which can now be done on-line at:  http://www.columbiaclinicaltrials.org

 

The process of completing the Protocol (IRB) module is much abbreviated and the detailed instructions are in the Table below.   If the protocol requires approval by the Cancer Center (PRMC), Joint Radiation Safety Committee (JRSC), or Institutional Biosafety Committee (IBC), this/these approval(s) must be obtained prior to submission to WIRB.  Copies of these approvals should be attached in Rascal and submitted with the application to WIRB.

 

2.         After completing the sections in the Protocol (IRB) module listed in the Table below, submit the protocol to the IRB.  The protocol will be returned to you by the IRB following confirmation that all of the required information has been included.  This process should take no more than 2 days.  The status of the Protocol within the IRB module will be “Returned.”   Correspondence will be sent from the IRB to the Principal Investigator that will state:

 

“You have permission to send this industry-sponsored, multi-centered clinical trial to the Western IRB for review”

 

You should copy this correspondence from the IRB and include it in your submission to the WIRB.

 

FOLLOWING APPROVAL BY THE WIRB

3.         As soon as approval from the WIRB is received, attach a copy of the WIRB approval letter and WIRB-approved consent form (provided electronically by the WIRB) to the RASCAL Protocol, Enter the WIRB number on the General page of the Rascal submission (just below the drop down box indicating Western IRB as IRB of record) and resubmit the protocol to the IRB. 

 

A completed CUMC IRB submission is required prior to institutional sign off on the contract and must include:

·        an attached copy of the WIRB approval letter and the WIRB approved consent form

TABLE:              Abbreviated Protocol (IRB) submission in RASCAL priorPRIOR to submission to WIRB.

Complete the following sections:

 

General*	Enter the department code	Submitting to:         Medical Center   Protocol End Date:         Enter an approx End Date   Title       Enter study title   Abbreviated Title       Enter abbreviated title (required by Rascal)			IMPORTANT!!!!   Enter title with prefix “WIRB” followed by the study title In section:   “If CU IRB is not the official IRB of record”   SELECT:   “Western IRB”   From the drop-down box.   The WIRB number will be added later	In Research Procedures check off the following: ·         Drug ·         Device ·         or both		In Research Facilities/Resources check off if applicable: ·         Radiation - need to separately submit to Joint Radiation Safety Committee and/or or Radioactive Drug Research Committee ·         Gene Transfer, Hazardous Materials, Biosafety – need to separately submit to Biosafety Committee ·         Cancer Center – need to submit to the Protocol Review Monitoring Committee
Personnel*	Add all Study Personnel (this will allow completion of study specific conflict of interest forms)
Research*	Enter the following statement in the study description:    “This protocol is being submitted to the WIRB for review”   This is the ONLY thing that needs to be in this section.  No lay abstract, etc.Rascal also requires some text be placed in the Hypothesis, the Scientific Abstract, and the Lay Abstract – this can be the same text.
Funding*	Select either external pharmaceutical or external medical device			Enter the Sponsor’s Name			Enter the Rascal Proposal (Grants and Contracts) Number
Investigational Product*	Add entry for each investigational drug or device	Select type:  Drug, Device or Biologic	Include name of drug, device, or biologic		Enter the Sponsor Protocol Number and Version   Include: o         IDE/IND Holder’s name o         IDE/IND number o         Phase of Study o         Sponsor’s Contact Information
Attach Documents*	Attach copies of sponsor’s protocol, investigator’s brochure, and sponsor’s draft Informed Consent (if provided). If these documents are not available in electronic form, bring paper copies to the IRB who will scan the document into a PDF file that can be attached.

 

*The headings refer to the menu choices in the Rascal IRB module