For New Studies

• Protocol Submission Checklist (follow the checklist within the form - incomplete applications will not be accepted by the ISERB) (updated August, 2009)
• Request for Scientific Review (updated August, 2009)
• Request for Expedited Review  (updated 9/08) (if applicable)
• Unaffiliated Investigator Agreement (for voluntary staff and/or non-SVCMC employees)
• Conflict of Interest Form - for all key personnel on all studies (new 1/08)
• Guidance: A Guide to Scientific Submissions

For New Studies with funding

• Corporate Administrative Review Form (updated 6/08)
  • This form includes a Specific Purpose Fund Authorization to set up study-specific finance accounts.
• If the sponsor is requesting a list of ISERB members, the ISERB provides the following letter.

Consent Document Templates/Information

• Consent Template (updated 12/07)
• Waiver of Informed Consent Application
• Waiver of Signed Consent Application (new 4/08) - PLEASE DO NOT SUBMIT BOTH A WAIVER OF INFORMED CONSENT APPLICATION AND A WAIVER OF SIGNED CONSENT APPLICATION.  A waiver of signed consent application is generally used to request an oral consent process.
• Biobanking Consent Instructions and Template

HIPAA Templates

• HIPAA Authorization (updated 7/09)
  • This HIPAA Authorization has a corrected signature page.  All new and continuing studies must used the revised HIPAA Authorizations.
  • This HIPAA Authorization has a repository/database section that is required for all protocols that have a repository or database.  The new section must be used in all new and continuing studies that have a repository or database.
• HIPAA Waiver/Alteration (updated 4/08)
• Data use agreement (only to be used when accessing a Limited Data Set - contact the ISERB for more information)

Unantcipated Problem (Adverse Event) Reporting  - new form required as of 1/1/09.  In order to activate the fields on the form, save the document to your computer and re-open it. 

• Form (new 12/31/08)
• Instruction Letter 

For Continuing Reviews

• Continuing Review Application
• Conflict of Interest Form - for all key personnel on all studies (new 1/08)
• For studies that are continuing to enroll subjects, submit the following:
  • Clean copy of the current consent document for review and stamping
  • For HIPAA Authorizations:
    • If the current HIPAA Authorization has an expiration date stamped on it, submit a clean copy for review and stamping, along with a note that states the HIPAA Authorization was stamped that way. 
    • If the current HIPAA Authorization does NOT have an expiration stamp on it (and the protocol does not include a database or repository), the HIPAA Authorization has been approved for the lifetime of the project.  It only needs to be resubmitted if a modification to the project requires a modification to the HIPAA Authorization (e.g. a change in PI).

For Modifications  

• Modification/Amendment Form (new 4/08)
• Updated Investigator's Brochure Cover Sheet (new 8/08)
• Written Information to be Provided to Subjects Submission Form (new 3/09) - this form is to be submitted to the ISERB along with all subject diaries, instruction cards and guides, subject incentives, subject recruitment material and other written information provided to subjects .  This form only needs to accompany these items when they are submitted outside of a new protocol application. This form has now been replaced by an xForm - see below.

Items that must be submitted using xForms on IRBManager (all items below will only be accepted by xForms as of October 2, 2009) (instructions for using IRBManager and xForms):

• Final Reports
• Protocol Exception Requests
• Protocol Violation Reports
• Updated Investigator Brochures
• Written Information and other Items Given to Subjects
• Notifications to the ISERB:
  • Annual Report
  • Closed to Enrollment notifications
  • Data Safety Monitoring Board/Committee Correspondence
  • Note for the ISERB file
  • Resume Enrollment notifications
  • Suspension of Study by Sponsor/PI notifications
  • Updated Package Insert submissions
  • Other Correspondence from Sponsor
  • other information that does not constitute an amendment to the protocol

 

Note that nearly all xForms will require the PI's electronic signature via the xForm.  The signature will be requested via an e-mail that will be sent from ISERB, ALERT.  PIs should be made aware of these e-mails.

For Final Reports:

• Electronic Submission of Terminations required as of 4/15/09.  Instructions are here.
• Note: Failure to submit a Final Report will result in suspension of the PI's research privileges at SVCMC.

If you would like to collect data from SVCMC medical charts for research purposes submit the following form along with your ISERB approval letter:

•  Medical Records Request (new 11/08)

If you need to access PHI to evaluate the feasibility of a project, please contact the ISERB for further guidance before submitting the following form:

• Preparatory to Research

Last updated September 25, 2009