OPRS News

8/12/08
New Forms Posted to the OPRS Website

8/4/08
New Form - Request to Continue Research Intervention

7/23/08
Guidance Document & Revised Front Sheet Template

6/19/08
New Alert Page Template and Guidance

4/4/08
Guidance Document: Consent for Continued Participation in a Research Study By a Young Adult Who Has Reached Age 18

4/1/08
New Procedures for Communicating Changes in Study-wide and DF/HCC Accrual Figures to OPRS and the IRB

1/11/08
Revised Application for Continuing Review Form

1/2/08
National Shortage of Radiopharmaceuticals and Protocols Deviations; Changes to OPRS Forms

10/4/07
Priority List Form Addition & Changes to Other Forms Including New Clinical Trials Application Form

7/26/07
OPRS Submit Enhancement and Amendment Submission Clarification

7/12/07
The Major Deviation/Violation/Exception Form Updated

7/12/07
OPRS Submit Enhancement for Dose Escalation Cohort Changes

4/30/07
Revised Forms and New Information Sheets Available

4/12/07
Overview of Policy Change

11/28/06
New OPRS Information Sheet – How to Contact the FDA

11/6/06
Various OPRS Update Highlights (compliance updates and more)

9/19/06
Preparing Endorsement Letters for New Protocols

9/11/06
ONCPRO Enhancement for New User Sign Up

8/24/06
Directed To Principal Investigators And Study Staff Of Protocols That Involve Tissue Collection

8/11/2006
The following news update from OPRS highlights CTEP CTCAE v3.0 Adverse Event Lay Terms

6/20/2006
The following news update from OPRS highlights new templates, letters and OPRS staff members

4/27/2006
The following news update from OPRS highlights various issues relating to protocol submissions and post-approval protocol events

4/13/06
OPRS Submit  Changes with Violations, Deviations and Exceptions 

2/13/06
DFCI Policy on Reporting Deviations/ Violations/ Exceptions to OPRS

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  • Office for Human Research Studies (OHRS)
    • Contacts
    • Information for Sponsors
    • Submitting A New Protocol
    • Consent Documents
    • After Activation Forms
    • HIPAA
    • OHRS Information Sheets
    • External Regulatory Guidance
    • OHRS News Updates
    • Oncology Protocol System and OHRS Submit
    • Presentation and Training Materials
    • Partners Policy and Guidance Links
  • Quality Assurance Office for Clinical Trials (QACT)
  • Clinical Research Unit (CRU)
  • Clinical Trials Education Office (CTEO)
  • Protocol Review and Monitoring System (PRMS)
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