Completing the CTSU Transmittal Sheet CTSU IRB Certification Form

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Completing the CTSU Transmittal Sheet CTSU IRB Certification Form Powered By Docstoc
					Completing the CTSU Transmittal Sheet & CTSU IRB Certification Form

Hints for CTSU Transmittal Sheet:

1. Sites with access to Acrobat Write software can save the forms to their systems and
   template the forms to include standard information, but please verify that the sites
   listed are approved for each protocol.

2. All forms must be legible.

3. Site must submit to the Central Regulatory Facility IRB approvals for all NCI
   sponsored phase adult Cooperative Group I, II & III prevention and treatment studies
   with the exception of STAR, SELECT, BCPT, PCPT & GOG 0190. *

4. Categories of IRB approvals that must be submitted to the Central Regulatory Facility
   include all initial approvals, continuing reviews** on studies open to accrual &
   treatment and mandatory amendments. ***

5. If submitting a group of IRB approvals you may batch multiple approvals under a
   single transmittal sheet and certification form when all items but either the protocol or
   site are the same on the IRB Certification form. For example you may send all
   protocol continuing reviews on a single transmittal and certification form if the date
   of review, sites and PI are the same.

6. List only the lead performance site on the CTSU Transmittal Sheet when multiple
   sites are included on the IRB Certification form.

7. Please include the contact information for the person responsible for the submission
   at your site.

Hints for CTSU IRB Certification Form:

1. The CTSU IRB Certification form is the preferred method for communicating IRB
   approval to the Central Regulatory Facility. In lieu of the certification form a
   completed and signed HHS 310 form or IRB memo containing all items outlined on
   the CTSU IRB Certification form will be accepted. IRB minutes can be used for
   supplemental documentation or clarification but cannot be the sole source of
   approval.

2. In block #1 give the assurance number of the institution where the reviewing IRB
   resides or the assurance number of the lead institution when all performance sites are
   covered under a single OHRP assurance. Please contact your local IRB regarding the
   correct assurance number for your institution.

3.    In block #2 check the review the applicable review type. Do not include continuing
     (annual renewals) and initial reviews on the same certification form. You may
     include version (amendment/revision) approvals with initial or continuing reviews as
     long as the version date is included in block #4.

4. In block # 3 list all performance sites covered under the IRB review for the
   protocol(s) listed in block # 4. Include the CTEP Institution codes for each
Guidance doc. Regulatory forms 6/17/03
   performance site. CTEP Institution codes can be located on your Cooperative Group
   web sites or by their Cooperative Group administrative office. ****

5. In block #4 list the lead Group protocol number indicating on the cover sheet of the
   protocol. Only include a version date if the submission is a version approval. The
   version date is clearly indicated on the cover sheet of the protocol.

6. In block #6, CTSU business rules dictate that all initial and continuing reviews must
   be full board approvals for protocols open to accrual and treatment. Appropriate
   documentation from the IRB must be submitted when an expedited IRB approval is
   submitted to the Central Regulatory Facility.

7. In block #9 - #14, CTSU business rules dictate that the IRB signatory must sign the
   CTSU IRB Certification form. Signatures of other site/IRB staff will only be
   accepted on the certification form if accompanied by a HHS 310 form or IRB memo
   signed by the IRB signatory.

   *Your affiliated Cooperative Group may require additional submission of regulatory
   materials to their administrative office. Please follow any additional procedures
   mandated by your Group administrative office.

   **The lead protocol Group may require that continuing review on studies in follow-
   up be submitted to the Central Regulatory Facility. This will be clearly stated in the
   regulatory instructions in the protocol.

   ***Mandatory amendments are defined as amendment where proof of IRB approval
   must be documented at the Central Regulatory Facility prior to continuing patient
   enrollments. The lead protocol Group will clearly state in the release of the
   amendment when the approval must be submitted to the Central Regulatory Facility.
   Verification of IRB approval for other protocol updates will be completed at time of
   audit.

   ****The Central Regulatory Office will enter only the sites listed on the CTSU IRB
   Certification Form.




Guidance doc. Regulatory forms 6/17/03