What to Include in a Study SmartForm

The SmartForm is the series of web-pages (or forms) where you can input specific information about a study.  The following section describes what information should go into each space of the SmartForm.

Important!  Completing elements of the SmartForm or Clicking “Finish” does not send the study for review.   The PI must click Submit (marked with a red arrow in the submission workspace) for the submission to proceed on for the next state of review.

SmartForm Section: Basic Information

1. Title of study. Enter the complete study title. Please avoid use of quotation marks in the study title. 

2. Short title. The short title identifies the study throughout the system, such as in your inbox and in an IRB reviewer's list of submissions to review. This should be 80 characters or less, and should not contain quotation marks. If left blank, the system will automatically pull in the first 80 characters of the (long) study title.

3. Brief description or abstract. Enter a brief description of the study or the study abstract. This should be 225 words or less.

4. Name of Principal Investigator. Enter the name of the Principal Investigator. For details on who may be listed in this space, please visit your IRB website or Investigator Manual. 

This field will default to the name of the person completing the form. It may be changed by selecting clear and typing the name in the space provided (a list will appear with names from which to select), or you can click the select option to search the list of names. Use the “%” symbol to replace portions of a name which are unclear or possibly not spelled correctly. This is called a “wildcard” character.

5. Does the investigator have a financial interest related to this research? Indicate if the Principal Investigator has a financial interest. For more information regarding what constitutes a financial interest, please visit your IRB website. If an individual has a financial interest, complete and attach “FORM: Financial Interest Disclosure Form” to the Supporting Documents page of the SmartForm.

6. Select the study's department. Indicate the name of the Principal Investigator or Faculty Sponsor’s department for this study.  Once chosen, saved and submitted, the department cannot be changed.

Type the department name in the space provided (a list will appear with options from which to select), or you can click the select option to search the list of available departments and schools. Use the “%” symbol to replace portions of a word of which may be unclear or possibly not spelled correctly. This is called a “wildcard” character.

If the department name does not appear on the list provided, contact estrhelp@harvard.edu for guidance on which department. 

Once chosen, saved and submitted, the department cannot be changed during review.  To change the department after a study is submitted (but before the first determination by the IRB):
1. Complete the Withdraw activity on the study in review
2. Click “Edit Study” to change the name of the department on the SmartForm
3. Click “Save” then “Exit” on the SmartForm menu
4. The PI must complete the Submit activity on the study to send it back to the IRB

7. Are you requesting that an external IRB act as the IRB of record for this study? Select Yes if you are submitting an application requesting that a Harvard IRB rely on the review of another IRB. Select No if you are requesting that a Harvard IRB review and approve the study.

If you selected Yes see section: Requesting External IRB Review.

8. Attach the Research Protocol or Relevant Request Form. Select and use the template provided on the SmartForm (or on your IRB website) that is appropriate for your project and the IRB to which you are submitting. Attach a copy of the completed protocol template, or if this application represents a request for a “Not Human Subjects Research determination”, attach “FORM: Not Human Subjects Research Determination.” Of note, a research protocol is required for Exemption Requests. Be sure to name the file in a manner that identifies it as your protocol.

SmartForm Section: Funding Sources

On this page include any pending/awarded funding sources or financial support for this study. Leave questions 1 and 2 blank to indicate that there is no funding for this study. Reminder: If the funding status changes following IRB determination, submit a modification to this study.

1. List any grant proposal that has been submitted to the sponsored programs office (SPA or OSP), any proposal that was created in GMAS, or any federal or other sponsored funding for the study. Find and add all funding sources listed in the Harvard Grants Management Application Suite (GMAS) that are associated with this study.

To search for funding in the space provided, begin typing the grant project ID, the grant PI full name (first and last name), or the GMAS fund number and a list will appear with options from which to select.

GMAS Chooser Drop Down

Begin If additional search options are needed, can click the ellipses […] button option to search the list of available funding sources.  Use the “%” symbol to replace portions of a word of which may be unclear or possibly not spelled correctly.  Click “Go” and select the correct funding source.  Click “OK” on the pop up.

GMAS detailed search box

2. List any financial support for this project from a non-sponsored source such as a department, gift or Harvard program. List all other funding sources. Attach a complete copy of the funding application or agreement for these listed sources to the Supporting Documents page of the SmartForm, when applicable, and remove or black-out any salary information.

SmartForm Section: Study Team Members

The Study Team Members page of the SmartForm should include the name of individuals that a) have contact with human subjects, b) have access to data that is identifiable (including data that is indirectly identifiable using a coding system or key); or c) are responsible for the design, conduct, or reporting of the research. Take care to follow the instructions that display on the SmartForm page.

1. List study team members with an HUID. Click “Add” to include all team members who have an HUID.  

Individuals can be selected from a list of names. Begin typing a piece of the person’s name in the space provided on the pop up, or you can click the “add” option to search the list of available names. Use the “%” symbol to replace portions of a name of which may be unclear or possibly not spelled correctly. This is called a “wildcard” character.  Use the email address column for search or as a guide to selecting the correct person.  If the correct person cannot be found via name or email, click the ellipses […].  Choose Filter by: UserID to search by HUID

If you would like a person on the study team to access ESTR, and his/her name does not appear in the search results; this individual must obtain an HUID. Please visit the ESTR support site Job Aids page for detailed instructions on how to obtain an HUID for use with ESTR.

Each of the individuals listed must complete human research training unless you clearly indicate that the individual is listed simply for access to this study record (in the Study Team Member details and via “Add comment” on the submission workspace).

Indicate whether each listed individual has a financial conflict of interest relating to the Human Research. For more information about what constitutes a conflict, please visit your IRB website. If an individual has a financial interest, complete “FORM: Financial Interest Disclosure Form” and attach it to item 2 on this page of the SmartForm.

2. List study team members without an HUID (by attaching the Non-Harvard Study Personnel Form) and/or attach other relevant documents. If an individual’s name does not appear in the search results available in question 1, attach a completed “FORM: Non-Harvard Study Personnel Form” This form should only list individuals, who were not able to be listed under item 1 in the Study Team Members section of the SmartForm. Each of the individuals listed must complete human research training. Individuals only listed on this form will not have access to ESTR. 

Indicate whether each listed individual has a financial conflict of interest relating to the Human Research. For more information about what constitutes a conflict, please visit your IRB website. If an individual has a financial interest, complete “FORM: Financial Interest Disclosure Form” and attach it here.

TIPSStudy Team Members Page:
  • Do not list the PI on this page. 
  • For studies with a non-faculty Principal Investigator and where the IRB requires, list the Faculty Sponsor on this page. 
  • Each of the individuals named as study team members must complete human subjects training (refer to your IRB website to learn about training requirements).
  • Include non-Harvard collaborators who meet these criteria only in the absence of their local IRB review.
  • After adding individuals to the list under question 1, view the status of any required Human Subjects Training by going to the submission workspace and clicking on the Project Contacts tab

.Project contacts tab view

 

SmartForm Section: Study Scope

1. Are there external sites where the Investigator will conduct or oversee the research? Mark yes here if there are any locations other than Harvard where this project will take place.

SmartForm Sub-Section: External Sites 

Identify all locations other than Harvard where this project will take place, indicate details about the site as prompted on the External Site details. Upload information for each external site to the Supporting Documents SmartForm.

2. Does the study involve the use of a drug in one or more persons other than use of an approved drug in the course of medical practice? Indicate if drugs, biologics, foods or dietary supplements are used in the Human Research. 

SmartForm Sub-Section: Drugs 

Identify all drugs, biologics, foods and dietary supplements (approved and unapproved) being used in the Human Research. For each, indicate whether it has an IND number and for those that do, ensure that the application includes one of the following: (a) sponsor protocol with the IND number; (b) communication from the sponsor with the IND number; or (c) communication from the FDA with the IND number. Additionally attach the following items: 
> Investigator Brochure for each investigational drug involved in the Human Research.
> Current Package Insert. Submit for each marketed drug involved in the Human Research.
> Validation of IND#, e.g. FDA Approval letter or Sponsor Protocol

3. Does the study involve: (1) The use of a device in one or more persons that evaluates the safety or effectiveness of that device, or (2) Data regarding the use of a device on human specimens? Indicate if a device is used in the Human Research.

SmartForm Sub-Section: Devices 

Identify all devices being evaluated for safety or effectiveness or as a comparator (approved and unapproved). For each, indicate whether it has an IDE number and for those that do, ensure that the application includes one of the following: (a) sponsor protocol with the IDE number; (b) communication from the sponsor with the IDE number; or (c) communication from the FDA with the IDE number. Indicate whether the device is being submitted under the “Abbreviated IDE requirements” in 21 CFR 812.2(b). Additionally attach the following items: 
> Current Product Information, e.g., Device Manual. Submit for each investigational device involved in the Human Research.
> Validation of IND# or IDE#, e.g. FDA Approval letter or Sponsor Protocol

SmartForm Section: Consent Forms and Recruitment Materials

1. Consent, Assent, Permission, and HIPAA Authorization Forms: Use the templates appropriate to your IRB to create and attach the following items. Visit your IRB website for additional instructions regarding how to create consent materials:

> Consent, Assent Forms, or Scripts including HIPAA Authorization Forms (as applicable). Consent/assent documents must include version date and/or version number. If any consent materials will be translated, attach the foreign language versions of materials and “FORM: Translation Attestation” to the Supporting Documents section of the SmartForm which appears later in the submission process.

> DHHS-approved sample consent document. Consent documents must include version date and/or version number. If consent materials will be translated, submit “FORM: Translation Attestation.”

2. Recruitment Materials: Each recruitment document, script, flyer, advertisement, etc. must include version date and/or version number. Guidance on what is appropriate to include and exclude within an advertisement can be found in “WORKSHEET: Advertisements” and/or “WORKSHEET: Payments.” Worksheets are available for reference on your IRB website or in the Library section of ESTR (linked on the left side of submission and personal workspaces). Advertising material must include version date and/or version number. 

If any of materials will be translated, attach the foreign language versions of materials and “FORM: Translation Attestation” to the Supporting Documents section of the SmartForm which appears later in the submission process. 

SmartForm Section: Supporting Documents

Attach supporting files, naming them as you want them to appear in the approval letter: Also, be sure to name the file itself in a manner that identifies it as associated with your study.  When uploading documents to this page, you are prompted to select the appropriate attachment category.  Select the correct category when uploading the first version and if possible minimize use of the “other” category.  Once chosen and saved, the attachment category cannot be changed. The suggested best practice for file names: StudyNumber_DocumentName_VersionNumber

  • Ancillary Approvals/Permissions. Submit approval letters or permissions from any additional office or organization reviewing this project (for example, a letter of support). If unavailable at the time of submission, plan to submit a copy to the IRB prior to implementing any study procedures.
  • Data use agreements or other Agreements. Submit copies of any documents authorizing the use of data, or other contracts or agreements associated with the study.
  • Debriefing Materials. If any of these materials will be translated, also submit a Translation Attestation Form.
  • External Site Information. If question 1 in the SmartForm Section: Study Scope indicated that there are external sites where the research will be conducted or overseen, submit an approval notice from each external site identified in the SmartForm. If unavailable at the time of submission, plan to submit a copy to the IRB prior to beginning any human subjects research at the external site(s).
  • Federal Department Requirements Checklists. Attach any required checklist associated with certain kinds of Federal funding (such as DOD, DOJ or EPA). 
  • Financial Interest Disclosure Form. Submit this form if the Principal Investigator self-identifies a financial conflict of interest related to the research on the SmartForm: Basic Information page. Forms for any other team members which self-identify a financial conflict of interest should be attached to the SmartForm: Study Team Members page.
  • Foreign Language Documents. Submit all translated study materials.
  • Funding Source Attachments. If not associated with GMAS and as applicable, submit a complete copy of the grant applications, subcontract, and/or any funding agreements regardless of funding source. 
  • Individual Investigator Agreement (IIA). When a non-Harvard collaborator will be covered under the Harvard IRB review and this person is not affiliated with another institution, submit this form here or attached a completed copy to the SmartForm: Study Team Members page.
  • IRB Cede Request Request. When multiple institutions are engaged in the Human Research, submit this form allowing an investigator to designate Harvard as the Reviewing Institution (responsible for IRB review) or Relying Institution only when such agreements are with non-Harvard Catalyst institutions. To request such an agreement with a Harvard Catalyst institution, visit this link.
  • PI’s Current CV (ICH-GCP E6 Only). Submit a copy of the Principal Investigator’s current (signed/dated) CV only when required by sponsor to follow the “International Council on Harmonisation – Good Clinical Practice E6.”
  • Radiation Safety Form. If the Human Research involves the use of approved or unapproved diagnostic or therapeutic radiation outside routine clinical practice, complete and submit “FORM: Radiation Safety.”
  • Sponsor Protocol including DHHS-approved protocol. Submit the sponsor protocol, if applicable. 
  • Study Instruments/Tools. Including all data collection instruments, questionnaires, surveys, focus group discussion guides, or interview guides. Do not include Case Report Forms. Study documents must include version date and/or version number. If any materials will be translated, submit “FORM: Translation Attestation.”
  • Translation Attestation Form. Submit this form at the time of initial application if any study documents will be administered in languages other than English. Obtain the PI and translator’s signature. This form must also be submitted as part of a study modification when requesting approval for the use of new study documents that will be translated. Submit the locally-approved, translated documents to the IRB when they become available. 

Upon selecting continue from this page, the browser will direct to the last page of the SmartForm where you will have the opportunity to select “Save & Exit” to return to the submission workspace.