OHRS News & Alerts
11/6/09Change in CTSU IRB Certification Letter for DF/HCC
10/23/09New OHRS Office Hours Program
10/22/09Change in Letter to Sponsors Document
8/14/09Updated Information Letters to Sponsors
8/14/09Training for Newly Enhanced OHRS Submit
7/1/09OHRS Forms & Information Sheet Changes
4/30/09Updated Program Leader List for Endorsement Forms
4/14/09OHRS Forms & Website Updates
4/2/09Notice Regarding IRB Review of Stimulus Fund-Related Protocols
2/23/09New OHRS Information Sheet & Related Changes
1/28/09Updated Policies & Procedures for the Endorsement of New Research Protocols
1/28/09Revised Forms Posted on OHRS Website
1/20/09OHRS Submit Submissions
12/31/08Notice of Revised OHRS Forms Posted for Use
12/23/08Inclement Weather and Holiday Scheduling
12/18/08Revisions to Letter to Sponsors Concerning DFCI IRB Policy on Re-Consenting Subjects
12/3/08Overview of the Operations of the DFCI Institutional Review Boards
12/2/08New Resources for Risk Language
11/3/08New & Revised OHRS Information Sheets Posted
9/19/08New Forms Posted on OHRS Website
8/12/08New Forms Posted to the OPRS Website
8/4/08New Form - Request to Continue Research Intervention
7/23/08Guidance Document & Revised Front Sheet Template
6/19/08New Alert Page Template and Guidance
4/4/08Guidance Document: Consent for Continued Participation in a Research Study By a Young Adult Who Has Reached Age 18
4/4/08OPRS Alert - Changes in Dose Preparation/Administration
4/1/08New Procedures for Communicating Changes in Study-wide and DF/HCC Accrual Figures to OPRS and the IRB
1/11/08Revised Application for Continuing Review Form
1/2/08National Shortage of Radiopharmaceuticals and Protocols Deviations; Changes to OPRS Forms
10/4/07Priority List Form Addition & Changes to Other Forms Including New Clinical Trials Application Form
7/26/07OPRS Submit Enhancement and Amendment Submission Clarification
7/12/07The Major Deviation/Violation/Exception Form Updated
7/12/07OPRS Submit Enhancement for Dose Escalation Cohort Changes
4/30/07Revised Forms and New Information Sheets Available
4/12/07Overview of Policy Change
11/28/06New OPRS Information Sheet – How to Contact the FDA
11/6/06Various 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
8/24/06Directed To Principal Investigators And Study Staff Of Protocols That Involve Tissue Collection
8/11/2006The following news update from OPRS highlights CTEP CTCAE v3.0 Adverse Event Lay Terms
6/20/2006The 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
4/13/06OPRS Submit Changes with Violations, Deviations and Exceptions
2/13/06DFCI Policy on Reporting Deviations/ Violations/ Exceptions to OPRS
11/22/05OPRS Alert - FDA Guidance for Estimating the Maximum Safe Starting Dose