OHRS News & Alerts

11/6/09
Change in CTSU IRB Certification Letter for DF/HCC

10/23/09
New OHRS Office Hours Program

10/22/09
Change in Letter to Sponsors Document

8/14/09
Updated Information Letters to Sponsors

8/14/09
Training for Newly Enhanced OHRS Submit

7/1/09
OHRS Forms & Information Sheet Changes

4/30/09
Updated Program Leader List for Endorsement Forms

4/14/09
OHRS Forms & Website Updates

4/2/09
Notice Regarding IRB Review of Stimulus Fund-Related Protocols

2/23/09
New OHRS Information Sheet & Related Changes

1/28/09
Updated Policies & Procedures for the Endorsement of New Research Protocols

1/28/09
Revised Forms Posted on OHRS Website

1/20/09
OHRS Submit Submissions

12/31/08
Notice of Revised OHRS Forms Posted for Use

12/23/08
Inclement Weather and Holiday Scheduling

12/18/08
Revisions to Letter to Sponsors Concerning DFCI IRB Policy on Re-Consenting Subjects

12/3/08
Overview of the Operations of the DFCI Institutional Review Boards

12/2/08
New Resources for Risk Language

11/3/08
New & Revised OHRS Information Sheets Posted

9/19/08
New Forms Posted on OHRS Website

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

4/4/08
OPRS Alert - Changes in Dose Preparation/Administration

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

11/22/05
OPRS Alert - FDA Guidance for Estimating the Maximum Safe Starting Dose