Office of Clinical Investigation

Forms

New Protocol Submissions

New Protocol (Full or Expedited Review)

Must be submitted in CHeRP IRB.

Other New Submissions

Statement of Exemption from Review Form	Must be submitted in CHeRP IRB.
Discarded/Stored Specimen Form	Must be submitted in CHeRP IRB.
Record/Database Review Form	Must be submitted in CHeRP IRB.
Request for Single Patient Emergency Treatment	Must be submitted in CHeRP IRB.
Stem Cells Form	Must be submitted in CHeRP IRB.
Humanitarian Devices Form	Must be submitted in CHeRP IRB.
Specimen, Data Repository and Registry Form	Must be submitted in CHeRP IRB.
Innovative Therapy

Active Protocols: During the Research
Please only use these forms if your protocol has NOT been converted to CHeRP.

Amendment Form	Checklist
Study Staff Amendment Form
Unanticipated Event Reporting Form	Updated! Includes Significant Deviations
Sponsor Letter Regarding Unanticipated Event
Statement of Compliance
Significant Exception Request Form
Completion Form

Miscellaneous

Addendum A: Research Staff & Personnel form (Please only use this form if your protocol has NOT been converted to CHeRP)
Request for Certification of Human Subject Training
Translation of Informed Consent Request Form	Instructions
Release of Medical Records
Pre-Review Criteria
Credential Commitment Statement
Credential Request Form
CHeRP Protocol Outline
Financial Disclosure for PI Relying on CH IRB Review	New! (May 2012)

Technical Help

MS WORD must be installed on your computer to access the forms. Forms should be completed electronically and paper copies should be delivered to the CCI office. Forms may not be hand written. Do not e-mail the completed CCI forms to us. Save a copy of the form on your computer for future reference. We plan to eventually move to complete online submission, however we are unable to implement this at the present time.

For MAC Users

When you first enter the site, you will see the password dialog box. If the dialog box does not have a field for the domain, you should enter your username as CHBOSTON\Username. Make sure you are using a \ NOT a / to separate the domain from the username. Enter your CHBoston password (it is the password you would use if you were logging into a hospital PC.)