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:
- When possible, ensure Consent or Recruitment Materials have at least a one-inch margin.
- Attach non-document type attachments which must be part of the review (such as compressed/zip, video, audio, or htm file formats) to the supporting documents section, using the attachment category "other".
- 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 filter-able Excel checklist of SmartForm attachments)
|
X |
Document Type |
SmartForm Page to Upload Document |
Question # |
|
Study SmartForm: Relevant only for non-External IRB projects |
|||
|
|
Research Protocol, Repository Protocol, or Non-Human Subjects Research Request Determination Form |
Basic Information |
last |
|
|
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 ESTR |
Study Team Members |
2 |
|
|
Study Team Financial Conflict of Interest Form |
Study Team Members |
2 |
|
|
Individual Investigator Agreement for non-Harvard Collaborators without an institutional affiliation |
Study Team Members (not for Site SmartForm) |
2 |
|
|
Drug Details, including package insert, verification of each IND number, or investigator brochure |
Drugs (studies involving Drugs only) |
1,2,3 |
|
|
Device Details, including product labeling/device instructions with investigator brochure, or verification of each IDE number |
Devices (studies involving devices only) |
1,3 |
|
|
Consent Forms (English version only) |
Local Site Documents |
1 |
|
|
HIPAA Authorization Form (English version only) |
Local Site Documents |
1 |
|
|
Consent Script, for non-written consent (English version only) |
Local Site Documents |
1 |
|
|
Parental permission or Assent (English version only) |
Local Site Documents |
1 |
|
|
Recruitment Materials, including fliers, advertisements and scripts (English version only) |
Local Site Documents |
2 |
|
|
Principal Investigator Financial Conflict of Interest Form (only if not previously attached) |
Local Site Documents |
last |
|
|
Surveys/Questionnaires/Interview Guide (Study Instruments/Tools) |
Local Site Documents |
last |
|
|
Non-English versions of Consent, Assent, Permission, Scripts or Recruitment Materials |
Local Site Documents |
last |
|
|
Research Location Information |
Local Site Documents |
last |
|
|
Debriefing Materials |
Local Site Documents |
last |
|
|
Grant materials or funding source attachments (if the grant is not included in GMAS) |
Local Site Documents |
last |
|
|
Data Use or other agreements |
Local Site Documents |
last |
| Ancillary Approvals/Permissions | Local Site Documents | last | |
|
|
Federal Department Requirements Checklists |
Local Site Documents |
last |
| PI's Current CV (ICH-GCP E6 Only) | Local Site Documents | last | |
|
|
Radiation Safety Form |
Local Site Documents |
last |
|
|
Sponsor Protocol including DHHS-approved protocol |
Local Site Documents |
last |
|
|
Individual Investigator Agreement for non-Harvard Collaborators without an institutional affiliation (only if not previously attached) |
Local Site Documents |
last |
|
|
Consent Forms (English version only) which are generalized for use across many sites. |
Study-Related Documents |
1 |
|
|
HIPAA Authorization Form (English version only) which are generalized for use across many sites. |
Study-Related Documents |
1 |
|
|
Consent Script, for non-written consent (English version only) which are generalized for use across many sites. |
Study-Related Documents |
1 |
|
|
Parental permission or Assent (English version only) which are generalized for use across many sites. |
Study-Related Documents |
1 |
|
|
Recruitment Materials, including fliers, advertisements and scripts (English version only) which are generalized for use across many sites. |
Study-Related Documents |
2 |
|
|
Surveys/Questionnaires/Interview Guide (Study Instruments/Tools) which are generalized for use across many sites. |
Study-Related Documents |
last |
|
|
Non-English versions of Consent, Assent, Permission, Scripts or Recruitment Materials which are generalized for use across many sites. |
Study-Related Documents |
last |
|
|
Debriefing Materials which are generalized for use across many sites. |
Study-Related Documents |
last |
|
|
Ancillary Approvals/Permissions which are generalized or are relevant for use across many sites. |
Study-Related Documents |
last |
| Site SmartForm: Relevant only for non-External IRB projects that are marked as Collaborative studies, where Harvard will review for at least one site. | |||
|
|
SmartIRB Cede Request Application (for when another IRB is relying on the Harvard IRB) |
Local Site Documents |
1 |
|
|
Draft or Final IRB Authorization Agreement (IAA) |
Local Site Documents |
1 |
|
|
Principal Investigator Financial Conflict of Interest Form (only if not previously attached) |
Local Site Documents |
1 |
|
|
Grant materials or funding source attachments (if the grant is not included in GMAS and only if not previously attached) |
Local Site Documents |
1 |
|
|
Site-specific study materials such as Consent, Assent, Recruitment or Data Collection tools or instruments. |
Local Site Documents |
1 |