Spring 2017 Quarterly Forms Update

June 05, 2017

Spring  2017 – May 15, 2017

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 atbdurie@partners.org

New Forms and Information Sheets

1.      Notice of Request to Initiate Reliance Agreement NEW

  • This new form is for requesting to rely on an external Single IRB instead of the DFCI IRB or NCI CIRB) for the review of DF/HCC. It should be submitted prior to the new protocol submission.  

2.      IS – Guidance – Massachusetts State Law Involving Human Research NEW

  • References to state laws pertaining to human research.

Template Revisions:

1.      Biomedical Protocol Template

Revisions to the DF/HCC Biomedical Protocol Template are minor and are described in the revised Protocol Template Log.  The DF/HCC 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 – Clinical Trials
  2. New Project Application – Single IRB
  3. New Project Application – Social/Behavioral Research
  4. New Project Application – Prospective Collection of Human Material and/or Clinical Data for Research Purposes
  5. New Project Application – Research Use of Retrospective Medical Records and/or Clinical Data for Research Purposes
  6. Endorsement Form
  7. Protocol Screening Form for Research Nursing and Study Team
  8. Alert Page Template
  9. Front Sheet
  10. Amendment Form
  11. Amendment Form – Single IRB
  12. Request to Add/Remove Site Form
  13. Research Team Update Form
  14. Change of PI / Site PI / Primary Study Contact / External PI Form
  15. Administrative Update Form
  16. Adverse Event Reporting Form
  17. Major Deviation / Violation / Exception Reporting Form

Information Sheet Revisions:

  1. IS – Index – Information Sheets
  2. IS – Operations – Completing the Front Sheet
  3. IS – Operations – Completing Endorsement Forms
  4. IS – Operations – Guidelines for Single IRB Review Process
  5. IS – Operations – Quick Reference for New Protocol Submissions
  6. IS – Operations – Request to Add-Site Checklist
  7. IS – Policy – Outside Interest Disclosure
  8. IS – Policy – Use of Alert Pages     

 

Summary of Revised Documents: 

1.    New Project Application for Clinical Trials

  • Administrative changes to sites in Part B.
  • Updated contact information throughout Part F.

2.    New Project Application – Single IRB

  • Added questions to Part A about the IRB of Record and basket studies.
  • Administrative changes to sites in Part C.

3.    New Project Application – Social/Behavioral Research

  • Administrative changes to sites in Part B.

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

  • Administrative changes to sites in Part B.

5.    New Project Application – Research Use of Retrospective Medical Records and/or Clinical Data for Research Purposes

  • Added questions about data collection and use to facilitate appropriate triage to Compliance Office.

6.    Endorsement Form

  • Updated site information.
  • Removed question about DF/HCC ownership in the drug or sponsor, as institutional conflict of interest related questions have been added to the new project applications.

7.    Protocol Screening Form for Research Nursing and Study Team

  • Administrative and editorial changes to align with changes in DF/HCC policies and procedures
  • Addition of the following Considerations to the form:
    • Trials requiring hospitalization
    • Trials requiring intra-tumoral injections
    • Trials that contain a vaccine
    • Trials that include drugs that are high risk for extravasation
    • Trials that include Engineered Cell Therapy

8.    Alert Page Template

  • Added instructional language to the Dose Escalation Table box to indicate that the dose levels listed must match what is listed in OnCore.

9.    Front Sheet

  • Updated and reformatted site utilization sections.

10. Amendment Form

  • Added a question to Part B to collect information for CTEP studies regarding when the amendment was posted to the CTSU website. This will aid OHRS in implementing the amendment locally within the 30-day requirement set forth by the Clinical Trials Monitoring Branch.
  • Added a new section called “OnCore Information” in preparation for replacing the Front Sheet Template with an OnCore generated report.  This section asks for information about revised OnCore fields which will allow OHRS to pull a revised Front Sheet report to be posted to OncPro.
  • Administrative corrections.

11. Amendment Form – Single IRB

  • Added a question to Part B to collect information for CTEP studies regarding when the amendment was posted to the CTSU website. This will aid OHRS in implementing the amendment locally within the 30-day requirement set forth by the Clinical Trials Monitoring Branch.
  • Added questions about participant payments and data management to Part B.
  • Added a new section called “OnCore Information” in preparation for replacing the Front Sheet Template with an OnCore generated report.  This section asks for information about revised OnCore fields which will allow OHRS to pull a revised Front Sheet report to be posted to OncPro.
  • Administrative corrections.

12. Request to Add/Remove Site Form

  • Updated site information.

13. Research Team Update Form

  • Revised Part B to ask for the date removed from study, which should match the date the staff member was removed from the Delegation of Authority Log.

14. Change of PI/Site PI/Primary Study Contact/External Investigator Form

  • Revised Parts B through D to ask for the date removed from the study, which should match the date the staff member was removed from the Delegation of Authority Log.

15. Administrative Update Form

  • Added PK Instructional Form to the list of documents that can be updated with this form.
  • Removed Pharmacy Manual and Study Procedure Manual from the list of documents that can be updated with this form.  Revisions to these documents now need to be submitted as an amendment.

16. Adverse Event Reporting Form

  • Administrative corrections.

17. Major Deviation / Violation / Exception Reporting Form

  • Added questions about CTEP and Institutional Conflict of Interest to Part in B to facilitate triage of submissions.

Summary of Revised Information Sheets

1. IS – Operations – Completing the Front Sheet

  • Revised site information at the bottom of the last page.

2. IS – Operations – Completing Endorsement Forms

  • Revised OHRS contact information.

3. IS – Operations – Guidelines for Single IRB Review Process

  • Added an overview of the new NIH Single IRB Policy
  • Revised to provide definitions of Single IRB terms, steps/criteria needed to initiate a new IRB Reliance Agreement
  •  Added an overview of the external IRBs DF/HCC currently works with.

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

  • Updated version dates for revised forms

5. IS – Operations – Request to Add-Site Checklist

  • Updated site information throughout.

6. IS - Policy - NIH Updated Genomic Data-Sharing Policy

  • Updated contact information and removed out of date link.

7. IS – Policy – Outside Interest Disclosure

  • Added language stating that failure to report a change in interest within 30 days is considered a minor violation to be consistent with the Outside Interest Disclosure Form.

8. IS – Policy – Use of Alert Pages     

  • Added language to indicate that the dose levels listed on the Dose Escalation Table must match what is listed in OnCore.

 

Please note that an error with the distribution list has caused a delay in this communication. Therefore, older versions of the templates and forms listed above will be accepted by OHRS longer than the typically allotted timeline.  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

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

www.dfhcc.harvard.edu/ohrs