OHRS News & Alerts

05/10/13
IMPORTANT: Research Community ListServ Communications

04/16/13
Quarterly Forms Update - Spring 2013

3/11/13
Off-Cycle Winter/Spring Forms Update

2/5/13
Quality Improvement Determination Form

1/11/13
Quarterly Forms Update - Winter 2013

11/15/12
Expanded Consent Language Database

11/9/12
OHRS Submit Downtime - OncPro will NOT be affected

10/9/12
Quarterly Forms Update - Fall 2012

9/7/12
OHRS Submit Downtime Due to Database Maintenance

8/10/12
OHRS Submit Downtime Due to LiveLink Upgrade Preparations

7/27/12
OHRS Submit Downtime Due to LiveLink Upgrade Preparations

7/26/12
Clarifications and Minor Form Corrections

7/13/12
OHRS Submit Downtime

7/9/12
OHRS Quarterly Forms Update - Summer 2012

6/20/12
Update on OncPro & OHRS Submit and Important Information Regarding OncPro Downtime

4/13/12
Spring Forms and Document Update

4/2/12
OncPro & 90 Day Reminder Notice Changes

2/27/12
Office for Human Research Studies (OHRS) Off Cycle FORMS UPDATE

1/6/12
Office for Human Research Studies (OHRS) QUARTERLY FORMS UPDATE Winter 2012

10/17/11
The Advance Notice of Proposed Rule Making (ANPRM)

10/12/11
OHRS Forms and Submission Update

9/26/11
Pre-Review Process for Adult Clinical Trials

9/1/11
OHRS Forms and Submission Update

8/26/11
Information Relating to the ANPRM Proposal to Revise the Human Subject Protection Regulations

7/1/11
OHRS Forms & Templates Updated

5/31/11
OHRS Forms Updated

5/6/11
Changes to OHRS Forms and Guidance

4/4/11
Upcoming Conference

3/4/11
Consent Form Reminders

2/16/11
OHRS Update Address

1/31/11
Open Letter to Sponsors Change

1/27/11
RTU Form, Add Site Checklist & CTSU Form Letter Change

1/20/11
Reminder Regarding Submissions of PDF documents to OHRS & Receipt of Courtesy Notices of Review Dates

11/3/10
Reminder to Principal Investigators of Responsibility to Review all IND/IDE Safety Reports

11/3/10
Continuing Review Form Changes

10/19/10
OHRS News Alert: Potential Safety Issue with Carboplatin Dosing and Serum Creatinine Measurement

8/13/10
Biomedical and Social/Behavioral Research Consent Form Changes

8/2/10
Reminder Regarding Policies for Reporting Non-Compliance in accordance with the Deviation/Violation/Exception Reporting Policy

6/21/10
OHRS Update On Guidance For Completing Protocol Front Sheets

6/18/10
OHRS Update On Research Staff Identified On Front Sheets

6/7/10
OHRS Updates - Continuing Review Form Revised & New Information Sheet Added Regarding Drug Shortage Procedures

5/14/10
New Guidance Pertaining to Participating Satellite Institutions, Informed Consent Template,& New Project Application Forms

4/22/10
OHRS News: Forms & CR Submission Time Frame Changes

4/14/10
Disease Program Leader List Updated

1/26/10
OHRS News Alert: FDA Notice Regarding Velcade

12/4/09
Revised Policy, Forms & Guidance Documents

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)

9/11/06
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