Checklist of Study SmartForm Attachments

Be prepared to attach several files to your study. While editing the study, several forms provide places to attach related files. In some cases, a template file is provided, such as for the protocol. When attaching each file:

  • Ensure Consent or Recruitment Materials have at least a one inch margin.
  • Name the file as you want it to appear on the IRB approval letter and ensure the file name clearly indicates what the file is and the study to which is belongs.  If document revision is needed, use the Update or Upload Revision option rather than deleting any files, whenever possible.

Reference the Library (linked on the left side of any workspace screen) any templates/forms that are requested within the SmartForm, along with guidance materials.

Attach the information listed below (if relevant to your study) to the location identified.
(view/print a quick image of the below table)

X
Document Type
SmartForm Page
to Upload Document

(in order of appearance, as applicable)
Question #
 Research Protocol or Not Human Subjects Research Determination Request FormBasic Information8
 IRB Cede Request Form or
Catalyst Cede Review Request Form
External IRB (External IRB studies only)

3

 External IRB Determination LetterExternal IRB (External IRB studies only)

4

 Study Personnel Form (listing team members who do not have an HUID)Study Team Members

2

 Human Subjects Training Certificate, if not already stored in ESTRStudy Team Members 

2

 Study Team Financial Conflict of Interest FormStudy Team Members

2

 Individual Investigator Agreement for non-Harvard Collaborators without an institutional affiliationStudy Team Members

2

 Drug Details, including package insert, verification of each IND number, or investigator brochureDrugs (studies involving Drugs only)

1,2,3

 Device Details, including product labeling/device instructions with investigator brochure, or verification of each IDE numberDevices (studies involving devices only)

1,3

 Consent Forms (English version only)Consent Forms and Recruitment Materials

1

 HIPAA Authorization Form (English version only)Consent Forms and Recruitment Materials

1

 Consent Script, for non-written consent (English version only)Consent Forms and Recruitment Materials

1

 Parental permission or Assent (English version only)Consent Forms and Recruitment Materials

1

 Recruitment Materials, including fliers, advertisements and scripts (English version only)Consent Forms and Recruitment Materials

2

 Principal Investigator Financial Conflict of Interest FormSupporting Documents

1

 Surveys/Questionnaires/Interview Guide (Study Instruments/Tools)Supporting Documents

1

 Non-English versions of Consent, Assent, Permission, Scripts or Recruitment MaterialsSupporting Documents

1

 Translation Attestation FormSupporting Documents

1

 External Site InformationSupporting Documents

1

 IRB Cede Request Form (for when another IRB is relying on the Harvard IRB)Supporting Documents

1

 Debriefing MaterialsSupporting Documents

1

 Grant materials or funding source attachments (if the grant is not included in GMAS)Supporting Documents

1

 Data Use or other agreementsSupporting Documents

1

 

Ancillary Approvals/Permissions Supporting Documents

1

 Federal Department Requirements ChecklistsSupporting Documents

1

 

PI's Current CV (ICH-GCP E6 Only)Supporting Documents

1

 Radiation Safety FormSupporting Documents

1

 Sponsor Protocol including DHHS-approved protocolSupporting Documents

1