# Checklist of 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: - 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](https://irb.harvard.edu/IRB/Rooms/DisplayPages/LayoutInitial?Container=com.webridge.entity.Entity%5BOID%5B932925EBAB2E8C458897BE431933015B%5D%5D) (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](/file_url/321)) Sort**X** **Document Type** **SmartForm Page to Upload Document** (in order of appearance, as applicable) **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* Sort**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 - [Logging In](/logging-in "Logging In") - [Creating a New Study](/creating-new-study "Creating a New Study") - [Study SmartForm](/study-smartform "What to Include in a Study SmartForm") - [Site SmartForm](/site-smartform "What to Include in a Site SmartForm") - [SmartForm Attachments](/checklist-study-smartform-attachments "Checklist of SmartForm Attachments") - [External IRB Submission](/ExternalIRB "Requesting External IRB Review") - [Editing a Submission](/editing-submission "Editing a Submission") - [Checking for Errors](/check-submission-errors "Checking a Submission for Errors") - [Submitting a Study](/submitting-a-study "Submitting a Study for Review") - [Checking the Status](/check-the-status "Checking the Status of a Submission") - [Accessing a Submission](/accessing-submission "Accessing a Submission") - [Responding to the IRB](/responding-to-irb "Responding to a Request for Clarifications or Modifications") - [Changing Study Documents](/changing-study-documents "Changing Documents on a Study") - [Communicating with Staff](/communicating-with-staff "Communicating with Staff During Review") - [Managing Related Projects](/managing-related-projects "Managing Related Projects") - [Finding the IRB Decision](/finding-IRB-determination "Finding Determination Letters and Approved Documents") - [Managing PI Proxy](/about-pi-proxy "Managing Principal Investigator (PI) Proxy") - [Changing a Primary Contact](/change-primary-contact "Changing the Study Primary Contact") - [Managing Guests](/about-study-guests "Managing Guests with View-Only Permissions to the Study") - [Copying a Study](/copy-submission "Copying a Study") - [Creating a Follow On](/create-followon "Creating a Follow-On Submission after Study Approval") - [Modification SmartForm](/mod-smartform "What to Include in a Modification SmartForm") - [Renewal(CR) SmartForm](/cr-smartform "What to Include in a Continuing Review SmartForm") - [RNI SmartForm](/rni-smartform "What to Include in a Reportable New Information SmartForm") - [Site Modification (for External IRB Update)](/ExternalIRB "Requesting External IRB Review") - [Closing a Study](/study-closure "Closing a Study") - [Generating Reports](/generating-reports "Generating Standard Reports")