Forms: Alphabetical Listing

Last Updated:

Adverse Event Reporting Form
	Reporting Guide , Definitions

06/13/2008

Adverse Event - Non-reportable events
	Reporting Guide , Definitions

10/17/2006

Confidentiality Agreement for Specimens

10/17/2006

Continuing Review/Study Closure Report
	-Required 05/01/2007 -Continuing Review Requirements (updated 4/16/2007) -When should you submit your Continuing Review Report? -Please read our Announcement about this form. NOTE: you must use a 2000 or newer version of Microsoft Word. Word 97 and older versions produce errors in how this form is viewed and printed.

06/13/2008

Cumulative Adverse Event Table for Continuing Review
	(EXCEL version)

04/29/2004

Deviation/Non-Compliance Reporting Form
	(Reporting Guide & Definitions, Minor Deviation Table for Continuing Review )

06/13/2008

Emergency Use
	Emergency Use Checklist Emergency Use Consent (if one not available from sponsor) Emergency Use Independent Physician Certification

06/13/2008
12/15/2006
12/15/2006
06/13/2008

Explicit Change Response

06/12/2008

Full Board Meeting Correction

06/13/2008

HDE - new submission
	(Humanitarian Use Device with Humanitarian Device Exemption)

01/28/2008

HDE - Continuing Review/Closure
	(Humanitarian Use Device with Humanitarian Device Exemption)

06/13/2008

Informed Consent Forms
	Use this link to visit a separate page dedicated to Informed Consent Forms. All of the different templates are available as well as other resources and instructions.

Introductory Questionnaire for Nonhuman/Exempt Studies

IQ Addenda:

A: Researcher Assurance

O: Request for Exempt Review

06/12/2008

Introductory Questionnaire for Full Board and Expedited Studies

IQ Addenda:	A: Researcher Assurance	J: Vulnerable Subjects
	B: Banking	K: Children
	C: Drugs	L: Conflict of Interest
	D: Devices	M: Expedited Review
	E: Experimental Procedures	N: Data Safety Monitoring Plan
	F: Radiation or Radioactive Materials	P: Prisoners
	G: Gene Therapy or Genetic Testing	S: Behavioral or Psychological Research
	H: Informed Consent Waiver to Enroll Subjects	V: VA
	I: Deception or Placebo	W: Pregnant Women, Fetuses, and Neonates

06/13/2008

I ntroductory Questionnaire: Tissue/Data Bank ONLY

06/13/2008

Principal Investigator Change
	Revision to permanently change the PI - signed by the old/departing PI and the new PI Must also submit the Revision form. Note: changing the PI on a study that is normally reviewed at the full Board must also be reviewed at full Board, so please take note of our full Board deadlines.

06/13/2008

Protocol
	"Sample" protocol with helpful information to remember/consider when writing your protocol. Read Protocol Template Guidelines before completing the protocol form. You may use the sponsor's protocol or GCRC protocol if available.

03/09/2004

Psychological and Survey Measure Form
	For new research that expects to use these types of measures with human participants.

10/17/2006

Revision

06/13/2008

Tabled Submission Response

06/13/2008

Temporary Transfer of Study Responsibility

10/17/2006

Unaffiliated Investigator Agreement (aka OHRP's Individual Investigator Agreement)

03/29/2007

Unanticipated Problem Reporting Form
	Reporting guide, Definitions

11/21/2007