OHRS Quarterly Forms Update - Fall 2016 - October 4, 2016

October 04, 2016

Office for Human Research Studies

 

QUARTERLY FORMS UPDATE

FALL  2016 – OCTOBER 4, 2016


General Announcements:

OHRS Smart Forms:  OHRS has started converting OHRS submission forms from Microsoft Word into an Adobe Acrobat PDF format (OHRS Smart Forms).  Our primary goal in converting these forms to a format the supports conditional and skip logic was to make them easier for study teams to complete, resulting in fewer returns by OHRS Intake Staff.  Reviewers will also have an easier time understanding the information presented, ensuring timely review determinations.  The appearance of each form will be different from the previous Word versions; however, the content and required information is the same. 

OHRS will be posting these forms for use on our website as they are developed. The forms can be filled out using Adobe Reader.  If you do not have Adobe Reader on your computer it can be downloaded from Adobe: https://acrobat.adobe.com/us/en/acrobat/pdf-reader.html

Any questions about “OHRS Smart Forms” can be directed to OHRS Operations Manager, Brian Durie at bdurie@partners.org

 

Template Revisions:

1.     Biomedical Consent Template

2.     Social/Behavioral Consent Template

Revisions to the DF/HCC Consent Templates are described in the revised Consent Template Logs.  The DF/HCC Consent Templates and Logs can be found on the OHRS under “Creation” and at the following link: http://www.dfhcc.harvard.edu/research/clinical-research-support/creation/forms-and-templates/

Document Revisions:

1.     New Project Application for Clinical Trials

2.     New Project Application – Central IRB

3.     New Project Application – Social/Behavioral Research

4.      New Project Application – Off Site Research

5.    New Project Application – Prospective Collection of Human Material and/or Clinical Data for Research Purposes

6.     New Project Application – Research Use of Medical Records and/or Previously Collected Specimens

7.     Front Sheet

8.     Research Funding Form

9.     Amendment Form

10.  Amendment Form – Central IRB

11.  Request to Add/Remove Site Form

12.  Add-Site Checklist

13.  Adverse Event Reporting Form

14.  Major Deviation/Violation/Exception – Other Event Reporting Form

15.  Minor Deviation/Violation Log

16.  Program Leader List for Endorsement Forms

17.  Application for Continuing Review

18.  Application for Continuing Review of Non-Interventional Research

19.  Application for Continuing Review - Central IRB

20.  Completion Form

21.  Outside Interest Form

22.  Statement of Principal Investigator

23.  Statement of Co-Investigator

24.  Study Specific Research Team Update Form

25.  Individual Specific Research Team Update

26.  Change of Principal/Site Responsible Investigator/Primary Study Contact/External Investigator Form

New Information Sheets:

1.     IS  - Guidance - DFCI IRB Approved Standard Drug Risk Language

2.     IS – Policy – Outside Interest Disclosure

Information Sheet Revisions:

1.     IS – Index – Information Sheets

2.     IS - Guidance - Guidance for Study Teams and Sponsors - Information Regarding Approvable and Not-Approvable Language in Consent Forms

3.     IS – Operations – Completing the Front Sheet

4.     IS – Operations – Quick Reference for New Protocol Submissions

5.     IS – Operations – Use of Informed Consent Documents Posting to OncPro

6.     IS – Policy – Adverse Event Reporting Policy

7.     IS – Policy – Non English Speaking Participants

 

Summary of Revised Documents:

1.     New Project Application for Clinical Trials

  • Added questions about data collection and use to Part D.
  • ·Revised questions about the use of ODQ and CTRIO in Part F.
  • Revised questions and contact information in the Biosafety section of Part F.
  • Added information about engineered cell therapies to the Cell Manipulation Labs section of Part F.
  • Added an additional signature line in Part H to ensure that Principal Investigators read and approve the consent form before it is submitted.
  • Minor administrative revisions.

2.     New Project Application – Social/Behavioral Research

  • Revised questions about the use of ODQ and CTRIO in Part C
  • Revised questions about the use of ODQ and CTRIO in Part E.
  • Minor administrative revisions.

3.     New Project Application – Central IRB

  • Revised questions about the use of ODQ and CTRIO in Part F.
  • Revised questions and contact information in the Biosafety section of Part F.
  • Added information about engineered cell therapies to the Cell Manipulation Labs section of Part F.
  • Minor administrative revisions.

4.     New Project Application – Off Site Research

  • Revised language about data and safety monitoring in Part A.
  • Minor administrative revisions.

5.     New Project Application – Prospective Collection of Human Material and/or Clinical Data for Research Purposes

  • Added questions about data collection and use to Part D.
  • Revised questions about the use of Biosafety Committee, ODQ and CTRIO in Part F.
  • Minor administrative revisions.

6.     New Project Application – Research Use of Medical Records and/or Previously Collected Specimens

  • Added questions about data collection and use to Part A.
  • Minor administrative revisions.

7.     Front Sheet

  • Added Engineered Cell Therapy to the “Protocol Involves” list.
  • Revised the name of Faulkner Hospital.

8.     Research Funding Form

  • Clarified language regarding funding status.

9.     Amendment Form

  • Added language to the Institutional Conflict of Interest (ICOI) section of Part B regarding changes to an ICOI Management Plan or Participant Information Sheet.
  • Reformatted Part C to improve clarity regarding notification of subjects.
  • Clarified language regarding dose escalations, therapy changes and data collation in the proposed changes table in Part D.
  • Revised questions about the use of Biosafety Committee, ODQ and CTRIO in Part G.
  • Added an additional statement of assurance in Part H to ensure that Principal Investigators read and approve the revised consent form before it is submitted.
  • Minor administrative revisions.

10.  Amendment Form – Central IRB

  • Added language to the ICOI section of Part B regarding changes to an ICOI Management Plan or Participant Information Sheet.
  • Reformatted Part C to improve clarity regarding notification of subjects.
  • Revised questions about the use of ODQ and CTRIO in Part G.
  • Minor administrative revisions.

11.  Request to Add/Remove Site Form

  • Added a statement regarding review of Add-site Amendments by the Office of Research Integrity (ORI) for potential ICOI prior to IRB review.
  • Added revised Radiation Safety Screening Form to the list of supplemental documents.
  • Minor administrative revisions.

12.  Add-site Checklist

  • Added a statement indicating that BWH must be listed as a site in order to add Faulkner Hospital.

13.  Adverse Event Reporting Form

  • Minor administrative revisions.

14.  Major Deviation/Violation/Exception – Other Event Reporting Form

  • Minor administrative revisions

15.  Minor Deviation/Violation Log

  • Revised to include an institution field.

16.Program Leader List for Endorsement Forms

  • Added Dr. Timothy Graubert to the Program Co-leaders for Transplant.

17.   Application for Continuing Review

  • Revised language in Part J regarding Institutional Conflict of Interest (ICOI) and Department of Defense (DoD) funding.
  • Minor administrative revisions.

18.   Application for Continuing Review of Non-Interventional Research

  • Added language in Part I regarding and Department of Defense (DoD) funding.
  • Minor administrative revisions.

19.  Application for Continuing Review - Central IRB

  • Minor administrative revisions.

20.  Completion Form

  • Revised part C, question 6 with updated information about registration with ODQ.

21.  Outside Interests Form

  • Combined the “Report of Change in Outside Interest” form and “Outside Interest Log” into one form to be used to report both interest for new studies and changes in interest for previously submitted studies.

22.Statement of Principal Investigator

  • Added statements of assurance about complying with conflict of interest policies to Part B.

23.Statement of Co-Investigator

  • Added statements of assurance about complying with conflict of interest policies to Part B.

24.Study Specific Research Team Update Form

  • Added a statement to the instructions box about adding staff directly into OnCore if your group has permission.
  • Added a statement to the instructions box about compliance with conflict of interest policies.

25.Individual Specific Research Team Update

  • Added a statement to the instructions box about adding staff directly into OnCore if your group has permission.
  • Added a statement to the instructions box about compliance with conflict of interest policies.

26.Change of Principal/Site Responsible Investigator/Primary Study Contact/External Investigator Form

  • Added information to the instructions box regarding compliance with conflict of interest policies.

27.  IS – Index – Information Sheets

  • Minor administrative revisions.

28.  IS - Guidance - Guidance for Study Teams and Sponsors - Information Regarding Approvable and Not-Approvable Language in Consent Forms

  • Added an important note about proofreading consent forms prior to submission to OHRS.

29.IS – Operations – Completing the Front Sheet

  • Added instruction for completing the “Mgmt group” field.

30.  IS – Operations – Quick Reference for New Protocol Submissions

  • Minor administrative revisions.

31.  IS – Operations – Use of Informed Consent Documents Posting to OncPro

  • Revised to explain changes that have been made to the consent footer in an effort to make the dates populated in the consent footer more often match the dates listed in OnCore.

32.  IS – Policy – Adverse Event Reporting Policy

  • Revised to require that ALL unexpected Grade 5 events must be communicated via email to the DFCI OHRS Event Reporting email box at the time of initial notification of the event.
  • Additional administrative corrections and clarifications

33.  IS – Policy – Non English Speaking Participants

·         Added a sentence stating that the phrase “Not for Subject Use” found in the header of unofficial versions is included in the header of non-English consent form documents and is not translated

Beginning Monday, October 31, 2016, older versions of the templates and forms listed above will no longer be accepted by OHRS.  Study teams are advised to always use the most recent version of each form from the OHRS website.  All forms are located on the OHRS website at: www.dfhcc.harvard.edu/research/clinical-research-support

Quarterly OHRS Forms Training will be held on Friday, October 14, 2016 in Yawkey 307 from 10:00-11:00am. 

Please email the DFCI OHRS Submit email box at: OHRS_Submit@dfci.harvard.edu with any problems related to a submission made via OHRS Submit (e.g. incorrect protocol number, incorrect forms, etc.).  The OHRS Intake team will take care of your request.

If you have any questions, please do not hesitate to contact us.

Office for Human Research Studies
Dana-Farber Cancer Institute
450 Brookline Ave., OS229
Boston, MA 02215
Phone: 617-632-3029
Pager: 42299
http://www.dfhcc.harvard.edu/research/clinical-research-support/