|
|
|
|
Dear IRB – February 2014 |
02/24/2014 |
|
The CRRO Corner – 2/2014: Upcoming Training at BUMC in Conduct of Clinical Research for 2014! |
02/24/2014 |
|
Documenting Informed Consent: What’s Required and Why – January 2014 |
01/17/2014 |
|
Things to Know – January 2014 |
01/17/2014 |
|
Congratulations – January 2014 |
01/17/2014 |
|
Dear IRB – January 2014 |
01/17/2014 |
|
The CRRO Corner – 1/2014: |
01/17/2014 |
|
Making a List and Checking It Twice – December 2013 |
12/16/2013 |
|
Things to Know – December 2013 |
12/16/2013 |
|
Congratulations – December 2013 |
12/16/2013 |
|
Dear IRB – December 2013 |
12/16/2013 |
|
The CRRO Corner – 12/2013: “Informed Consent Forms: Are the Required Elements of Consent Present and Complete?” |
12/16/2013 |
|
Preparing an IRB Application – Where Do I Begin? – November 2013 |
11/22/2013 |
|
Things to Know – November 2013 |
11/22/2013 |
|
Congratulations – November 2013 |
11/22/2013 |
|
Dear IRB – November 2013 |
11/22/2013 |
|
The CRRO Corner – 11/2013: Attitudes toward Medical Research |
11/22/2013 |
|
Exploring IRB Review Options for Clinical Record Review – October 2013 |
10/31/2013 |
|
Things to Know – October 2013 |
10/31/2013 |
|
Congratulations – October 2013 |
10/31/2013 |
|
Dear IRB – October 2013 |
10/31/2013 |
|
The CRRO Corner – 10/2013:“Going Retro” – Exempt Category 4 Submissions for Retrospective Chart reviews, and other studies using existing data/samples |
10/31/2013 |
|
Is Exempt Review Right For You? – September 2013 |
09/27/2013 |
|
Things to Know – September 2013 |
09/27/2013 |
|
Congratulations – September 2013 |
09/27/2013 |
|
Dear IRB – September 2013 |
09/27/2013 |
|
The CRRO Corner – 9/2013: Timing study procedures and visits – Do you do “windows”? |
09/27/2013 |
|
Things to Know – June 2013 |
06/21/2013 |
|
Congratulations – June 2013 |
06/21/2013 |
|
Dear IRB – June 2013 |
06/21/2013 |
|
The CRRO Corner – 6/2013: Adverse Event / Unanticipated Problem Documentation – What is “Expected”? |
06/21/2013 |
|
Research Repositories (Part III) – Data Use Agreements and Materials Transfer Agreements – June 2013 |
06/21/2013 |
|
Things to Know – May 2013 |
05/21/2013 |
|
Congratulations – May 2013 |
05/21/2013 |
|
The CRRO Corner – 5/2013: A Community-Based Approach to Human Subjects Research |
05/21/2013 |
|
Research Repositories (Part II) – IRB Review of Repositories – May 2013 |
05/21/2013 |
|
Things to Know – April 2013 |
04/18/2013 |
|
Congratulations – April 2013 |
04/18/2013 |
|
Dear IRB – April 2013 |
04/18/2013 |
|
The CRRO Corner – 4/2013: Informed Consent Form “valid through” date – What does that mean? |
04/18/2013 |
|
Research Repositories (Part I) – Understanding Recipient Research Proposals – April 2013 |
04/18/2013 |
|
Privacy and Confidentiality Requirements in the Use and Disclosure of Information for Research – March 2013 |
03/19/2013 |
|
Things to Know – March 2013 |
03/19/2013 |
|
Congratulations – March 2013 |
03/19/2013 |
|
Dear IRB – March 2013 |
03/19/2013 |
|
The CRRO Corner – 3/2013: Upcoming Clinical Research Training |
03/19/2013 |
|
Developing an Effective Recruitment Plan for Clinical Research Studies – February 2013 |
02/25/2013 |
|
Things to Know – February 2013 |
02/25/2013 |
|
Congratulations – February 2013 |
02/25/2013 |
|
Dear IRB – February 2013 |
02/25/2013 |
|
The CRRO Corner – 2/2013: “Study-Specific Training” |
02/25/2013 |
|
dbGaP – Sharing and Accessing Data – January 2013 |
01/30/2013 |
|
Things to Know – January 2013 |
01/30/2013 |
|
Congratulations – January 2013 |
01/30/2013 |
|
Dear IRB – January 2013 |
01/30/2013 |
|
The CRRO Corner – 1/2013: What?s “Independent”? |
01/30/2013 |
|
i2b2 and the MDHR: New tools for rapid, easy access to clinical data for health outcome assessment and research – December 2012 |
12/17/2012 |
|
Things to Know – December 2012 |
12/17/2012 |
|
Congratulations – December 2012 |
12/17/2012 |
|
Dear IRB – December 2012 |
12/17/2012 |
|
The CRRO Corner – 12/2012: Strategies to Improve Minority Recruitment in Research Studies |
12/17/2012 |
|
Unique Challenges in Community-Based Participatory Research – November 2012 |
11/27/2012 |
|
Things to Know – November 2012 |
11/27/2012 |
|
Congratulations – November 2012 |
11/27/2012 |
|
Dear IRB – November 2012 |
11/27/2012 |
|
The CRRO Corner – 11/2012: BUMC StudyFinder is live! |
11/27/2012 |
|
Survey says…Exempt! – October 2012 |
10/30/2012 |
|
Things to Know – October 2012 |
10/30/2012 |
|
Congratulations – October 2012 |
10/30/2012 |
|
Dear IRB – October 2012 |
10/30/2012 |
|
The CRRO Corner – 10/2012: How to Advertise and Recruit at BU/BMC |
10/30/2012 |
|
You Should Count on It: Statistical Considerations When Planning Research Studies – September 2012 |
09/25/2012 |
|
Things to Know – September 2012 |
09/25/2012 |
|
Congratulations – September 2012 |
09/25/2012 |
|
Dear IRB – September 2012 |
09/25/2012 |
|
The CRRO Corner – 9/2012: Publicize Your Study! Have You Created a StudyFinder Listing Yet? |
09/25/2012 |
|
Things to Know – June 2012 |
06/28/2012 |
|
Congratulations – June 2012 |
06/28/2012 |
|
Dear IRB – June 2012 |
06/28/2012 |
|
The CRRO Corner – 6/2012: The ReSPECT Registry: A Recruitment Resource for Investigators |
06/28/2012 |
|
Test Your GCP Knowledge Quiz – June 2012 |
06/26/2012 |
|
You Just Can’t Take It With You! – May 2012 |
05/30/2012 |
|
Things to Know – May 2012 |
05/30/2012 |
|
Congratulations – May 2012 |
05/30/2012 |
|
Dear IRB – May 2012 |
05/30/2012 |
|
The CRRO Corner – 5/2012: Appropriate Language Regarding Financial Payment in Research Studies |
05/30/2012 |
|
Tracking Individual Consent Histories for Participants in Research – April 2012 |
04/27/2012 |
|
Things to Know – April 2012 |
04/27/2012 |
|
Congratulations – April 2012 |
04/27/2012 |
|
Dear IRB – April 2012 |
04/27/2012 |
|
The CRRO Corner – 4/2012:“Going Retro ..” Exempt Category 4 Submissions |
04/27/2012 |
|
Do the Usual Rules Apply? Special Considerations When Conducting Research With Children – March 2012 |
03/29/2012 |
|
Things to Know – March 2012 |
03/29/2012 |
|
Congratulations – March 2012 |
03/29/2012 |
|
Dear IRB – March 2012 |
03/29/2012 |
|
The CRRO Corner – 3/2012: Use the ReSPECT Registry to Recruit for Your Next Study! |
03/29/2012 |
|
Strategies to Help Ensure Validity of Web-based Research Samples – February 2012 |
02/22/2012 |
|
Things to Know – February 2012 |
02/22/2012 |
|
Congratulations – February 2012 |
02/22/2012 |
|
Dear IRB – February 2012 |
02/22/2012 |
|
The CRRO Corner – 2/2012: FDA Cited Violations in 2011 |
02/22/2012 |
|
Taking the Bite Out of the BARC: Getting Specimens from the BUMC Biospecimen Archive Research Core is Easier Than You Think! – January 2012 |
01/24/2012 |
|
Things to Know – January 2012 |
01/24/2012 |
|
Congratulations – January 2012 |
01/24/2012 |
|
Dear IRB – January 2012 |
01/24/2012 |
|
From the CRRO – 1/2012: Waiving Elements of Consent |
01/24/2012 |
|
Ethics Around the World: International Projects and the BUMC IRB – December 2011 |
12/20/2011 |
|
Things to Know – December 2011 |
12/20/2011 |
|
Congratulations – December 2011 |
12/20/2011 |
|
Dear IRB – December 2011 |
12/20/2011 |
|
From the CRRO – 12/2011: Benefits and Disadvantages of Mass Media as a Recruitment Tool |
12/20/2011 |
|
Measure Twice, Submit Once: Improving IRB Turnaround Times – November 2011 |
11/28/2011 |
|
Things to Know – November 2011 |
11/28/2011 |
|
Congratulations – November 2011 |
11/28/2011 |
|
Dear IRB – November 2011 |
11/28/2011 |
|
From the CRRO – 11/2011: Clinical Research Resources Office (CRRO) Pre-reviews |
11/28/2011 |
|
Clinical Research Recruitment and Retention: Barriers and Strategies – October 2011 |
10/31/2011 |
|
Things to Know – October 2011 |
10/31/2011 |
|
Congratulations – October 2011 |
10/31/2011 |
|
Dear IRB – October 2011 |
10/31/2011 |
|
From the CRRO – 10/2011: Take the CRRO Informed Consent Form Challenge |
10/31/2011 |
|
Extra! Extra! The HHS Proposes Changes to the Regulations Governing Human Subjects Research – September 2011 |
09/21/2011 |
|
Things to Know – September 2011 |
09/21/2011 |
|
Congratulations – September 2011 |
09/21/2011 |
|
Dear IRB – September 2011 |
09/21/2011 |
|
From the CRRO – 9/2011: Trouble recruiting for your study? Consider contacting the CRRO Recruitment Services Program! |
09/21/2011 |
|
Things to Know – June 2011 |
06/30/2011 |
|
Congratulations – June 2011 |
06/30/2011 |
|
Dear IRB – June 2011 |
06/30/2011 |
|
From the CRRO – 6/2011: Using Notes-to-File in Research |
06/30/2011 |
|
BE OUR GUEST – June 2011 |
06/30/2011 |
|
Things to Know – May 2011 |
05/31/2011 |
|
Congratulations – May 2011 |
05/31/2011 |
|
Dear IRB – May 2011 |
05/31/2011 |
|
From the CRRO – 5/2011: School’s out for summer, but the CRRO is still hard at work! |
05/31/2011 |
|
Developing a Corrective Action Plan – May 2011 |
05/31/2011 |
|
Things to Know – April 2011 |
04/27/2011 |
|
Congratulations – April 2011 |
04/27/2011 |
|
Dear IRB – April 2011 |
04/27/2011 |
|
From the CRRO – 4/2011: Early Stage Quality Assurance Reviews |
04/27/2011 |
|
What’s New in Continuing Review? – April 2011 |
04/27/2011 |
|
ARE YOU CONSENT COMPLIANT ? – March 2011 |
03/30/2011 |
|
Things to Know – March 2011 |
03/30/2011 |
|
Congratulations – March 2011 |
03/30/2011 |
|
Dear IRB – March 2011 |
03/30/2011 |
|
From the CRRO – 3/2011: Coming Soon: Study Finder |
03/30/2011 |
|
Coming Soon to an IRB Near You … INSPIR II – February 2011 |
02/24/2011 |
|
Things to Know – February 2011 |
02/24/2011 |
|
Congratulations – February 2011 |
02/24/2011 |
|
Dear IRB – February 2011 |
02/24/2011 |
|
From the CRRO – 2/2011: Ensuring Study Quality with the Help of Self-Assessment Checklists |
02/24/2011 |
|
BANISHING BANKING BEWILDERMENT: Considerations for Banking Tissue Samples and Data – January 2011 |
01/28/2011 |
|
Things to Know – January 2011 |
01/28/2011 |
|
Congratulations – January 2011 |
01/28/2011 |
|
Dear IRB – January 2011 |
01/28/2011 |
|
From the CRRO – 1/2011: Resolving to Connect Ethics and Regulations |
01/28/2011 |
|
On Being Engaged – December 2010 |
12/22/2010 |
|
Things to Know – December 2010 |
12/22/2010 |
|
Congratulations – December 2010 |
12/22/2010 |
|
Dear IRB – December 2010 |
12/22/2010 |
|
From the CRRO – 12/2010: The Boston HealthNet: “A Strategy to Recruit Boston’s Diverse Populations” |
12/22/2010 |
|
Fitting Round Subjects into Round Holes – The Importance of Eligibility Criteria – November 2010 |
11/29/2010 |
|
Things to Know – November 2010 |
11/29/2010 |
|
Congratulations – November 2010 |
11/29/2010 |
|
Dear IRB – November 2010 |
11/29/2010 |
|
From the CRRO – 11/2010: Trouble recruiting for your study? Consider using the ReSPECT Registry! |
11/29/2010 |
|
Choosing the Right Path: How to Identify if a Study Qualifies for Expedited Review – October 2010 |
10/29/2010 |
|
Things to Know – October 2010 |
10/29/2010 |
|
Congratulations – October 2010 |
10/29/2010 |
|
Dear IRB – October 2010 |
10/29/2010 |
|
From the CRRO – 10/2010: Getting your study documents in order with Regulatory Binder Tabs |
10/29/2010 |
|
Things to Know – September 2010 |
09/29/2010 |
|
Congratulations – September 2010 |
09/29/2010 |
|
Dear IRB – September 2010 |
09/29/2010 |
|
From the CRRO – 9/2010: When the Consent Forms and Study Protocol Do Not Match |
09/29/2010 |
|
What We Did on Summer Vacation – September 2010 |
09/29/2010 |
|
GCP – What Is It and Why Does It Matter To Me? – June 2010 |
06/29/2010 |
|
Things to Know – June 2010 |
06/29/2010 |
|
Congratulations – June 2010 |
06/29/2010 |
|
Dear IRB – June 2010 |
06/29/2010 |
|
From the Auditor’s Desk – 6/2010: Approval and Use of Recruitment Materials |
06/29/2010 |
|
A Clear and Present Purpose – May 2010 |
05/27/2010 |
|
Things to Know – May 2010 |
05/27/2010 |
|
Congratulations – May 2010 |
05/27/2010 |
|
Dear IRB – May 2010 |
05/27/2010 |
|
From the Auditor’s Desk – 5/2010: Introducing Early Stage Quality Assurance Reviews |
05/27/2010 |
|
Principal Investigator Oversight – April 2010 |
04/29/2010 |
|
Things to Know – April 2010 |
04/29/2010 |
|
Congratulations – April 2010 |
04/29/2010 |
|
Dear IRB – April 2010 |
04/29/2010 |
|
From the Auditor’s Desk – 4/2010: OHRP Warning Letters: Cracking Down on PI “Undersight” |
04/29/2010 |
|
All About Class: IDE Requirements for Clinical Investigations – March 2010 |
03/26/2010 |
|
Things to Know – March 2010 |
03/26/2010 |
|
Congratulations – March 2010 |
03/26/2010 |
|
Dear IRB – March 2010 |
03/26/2010 |
|
From the Auditor’s Desk – 3/2010: IRB approved? Check. Okay to start the study? Not so fast! |
03/26/2010 |
|
What’s the Use? Understanding the Basics about INDs and IDEs – Part I-INDs – February 2010 |
02/26/2010 |
|
Things to Know – February 2010 |
02/26/2010 |
|
Congratulations – February 2010 |
02/26/2010 |
|
Dear IRB – February 2010 |
02/26/2010 |
|
From the Auditor’s Desk – 2/2010: When to Pull the “Emergency Brake” |
02/26/2010 |
|
The Final Frontier: IRB Final Reports – January 2010 |
01/26/2010 |
|
Things to Know: January 2010 |
01/26/2010 |
|
Congratulations: January 2010 |
01/26/2010 |
|
Dear IRB: January 2010 |
01/26/2010 |
|
From the Auditor’s Desk – 1/2010: FDA Warning Letters |
01/26/2010 |
|
Therapeutic Misconception: Crouching Research, Hidden Meaning – December 2009 |
12/15/2009 |
|
Things to Know: December 2009 |
12/15/2009 |
|
Congratulations: December 2009 |
12/15/2009 |
|
Dear IRB: December 2009 |
12/15/2009 |
|
From the Auditor’s Desk – 12/09: Laboratory and Other Test Reports and You |
12/15/2009 |
|
Dramatic Changes to HIPAA Will Greatly Affect Business Associates with Research Contracts – November 2009 |
11/23/2009 |
|
Things to Know: November 2009 |
11/23/2009 |
|
Congratulations: November 2009 |
11/23/2009 |
|
Dear IRB: November 2009 |
11/23/2009 |
|
From the Auditor’s Desk – 11/09: The Delegation of Responsibility Log – What’s that? |
11/23/2009 |
|
Clinical Trials Registration – October 2009 |
10/30/2009 |
|
Things to Know: October 2009 |
10/30/2009 |
|
Congratulations: October 2009 |
10/30/2009 |
|
Dear IRB: October 2009 |
10/30/2009 |
|
From the Auditor’s Desk – 10/09: Documenting the Informed Consent Process |
10/30/2009 |
|
Follow the Money – September 2009 |
09/29/2009 |
|
Things to Know: September 2009 |
09/29/2009 |
|
Congratulations: September 2009 |
09/29/2009 |
|
Dear IRB: September 2009 |
09/29/2009 |
|
From the Auditor’s Desk – 9/09: When the IRB Takes a Closer Look at Study Funding |
09/29/2009 |
|
Things to Know: June 2009 |
06/18/2009 |
|
Congratulations: June 2009 |
06/18/2009 |
|
Dear IRB: June 2009 |
06/18/2009 |
|
From the Auditor’s Desk – 6/09: Source Documents, Case Report Forms, and “ALCOA” |
06/18/2009 |
|
BUMC’s Policy on Investigators’ Conflicts of Interest: Updated Guidance – June 2009 |
06/18/2009 |
|
Things to Know: May 2009 |
05/26/2009 |
|
Congratulations: May 2009 |
05/26/2009 |
|
Dear IRB: May 2009 |
05/26/2009 |
|
From the Auditor’s Desk – 5/09: Game Over! – Stopping Research Activities When IRB Approval Expires |
05/26/2009 |
|
Investigator Rules of Engagement – May 2009 |
05/26/2009 |
|
Things to Know: April 2009 |
04/23/2009 |
|
Congratulations: April 2009 |
04/23/2009 |
|
Dear IRB: April 2009 |
04/23/2009 |
|
From the Auditor’s Desk – 4/09: Recording Signature Dates on the Informed Consent Form |
04/23/2009 |
|
When the Participation of a Research Subject is Discontinued – April 2009 |
04/23/2009 |
|
Making and Keeping Consent Promises – March 2009 |
03/26/2009 |
|
Things to Know: March 2009 |
03/26/2009 |
|
Congratulations: March 2009 |
03/26/2009 |
|
Dear IRB: March 2009 |
03/26/2009 |
|
From the Auditor’s Desk – 3/09: News and Tips on Protocol Deviation Reports and Protocol Exception Requests |
03/26/2009 |
|
Aiming for the Right Sample Size – February 2009 |
02/26/2009 |
|
Things to Know: February 2009 |
02/26/2009 |
|
Congratulations: February 2009 |
02/26/2009 |
|
Dear IRB: February 2009 |
02/26/2009 |
|
From the Auditor’s Desk – 2/09: Study Progress Reports and Accrual Numbers: Who is a Subject? |
02/26/2009 |
|
Minding your Bs and Ps: The Purpose of the DSMB and its Role in the Overall DSMP – January 2009 |
01/23/2009 |
|
Things to Know: January 2009 |
01/23/2009 |
|
Congratulations: January 2009 |
01/23/2009 |
|
Dear IRB: January 2009 |
01/23/2009 |
|
From the Auditor’s Desk – 1/09: The Top Three Most Common Protocol Deviations |
01/23/2009 |
|
Looking for New Year’s Resolutions? Five Possible Resolutions for Investigators and Study Staff – December 2008 |
12/18/2008 |
|
Things to Know: December 2008 |
12/18/2008 |
|
Congratulations: December 2008 |
12/18/2008 |
|
Dear IRB: December 2008 |
12/18/2008 |
|
From the Auditor’s Desk – 12/08: Using a Valid Informed Consent Form Document |
12/18/2008 |
|
A Closer Look at Risk -Benefit Analysis – November 2008 |
11/25/2008 |
|
Things to Know: November 2008 |
11/25/2008 |
|
Congratulations: November 2008 |
11/25/2008 |
|
Dear IRB: November 2008 |
11/25/2008 |
|
From the Auditor’s Desk – 11/08: Study Closure and Transferring a Protocol to another Investigator |
11/25/2008 |
|
Releasing Research Results to Subjects – October 2008 |
10/30/2008 |
|
Things to Know: October 2008 |
10/30/2008 |
|
Congratulations: October 2008 |
10/30/2008 |
|
Dear IRB: October 2008 |
10/30/2008 |
|
From the Auditor’s Desk – 10/08: Reporting Adverse Events on Study Progress Reports |
10/30/2008 |
|
The Language of Consent: Using the Short Form Process when Consenting non-English Speaking Subjects in Research – September 2008 |
09/25/2008 |
|
Things to Know: September 2008 |
09/25/2008 |
|
Congratulations: September 2008 |
09/25/2008 |
|
Dear IRB: September 2008 |
09/25/2008 |
|
From the Auditor’s Desk – 9/08: Subject withdrawal from Research and Respect for Persons |
09/25/2008 |
|
Using the Internet to Conduct Research and Recruit Subjects – June 2008 |
06/25/2008 |
|
Things to Know: June 2008 |
06/25/2008 |
|
Congratulations: June 2008 |
06/25/2008 |
|
Dear IRB: June 2008 |
06/25/2008 |
|
From the Auditor’s Desk – 6/08: Subjects’ signature on the informed consent form: Is it always required? |
06/25/2008 |
|
The Right Prescription: Working with the Investigational Drug Service At Boston Medical Center – May 2008 |
05/15/2008 |
|
Things to Know: May 2008 |
05/15/2008 |
|
Congratulations: May 2008 |
05/15/2008 |
|
Dear IRB: May 2008 |
05/15/2008 |
|
From the Auditor’s Desk – 5/08: Eliminating study procedures: Is IRB approval required? |
05/15/2008 |
|
Quality Assurance, Research and Everything In-Between – April 2008 |
04/24/2008 |
|
Things to Know: April 2008 |
04/24/2008 |
|
Congratulations: April 2008 |
04/24/2008 |
|
Dear IRB: April 2008 |
04/24/2008 |
|
From the Auditor’s Desk – 4/08: Principal Investigator’s Responsibilities Prior To Leaving BUMC |
04/24/2008 |
|
Case Report Forms – Critical to the Success of your Research Study – March 2008 |
03/14/2008 |
|
Things to Know: March 2008 |
03/14/2008 |
|
Congratulations: March 2008 |
03/14/2008 |
|
Dear IRB: March 2008 |
03/14/2008 |
|
From the Auditor’s Desk – 3/08: Corrective Action Plans – Is Your Plan Still Effective? |
03/14/2008 |
|
Utilizing Imaging for Research through Radiology at BUMC – February 2008 |
02/20/2008 |
|
Things to Know: February 2008 |
02/20/2008 |
|
Congratulations: February 2008 |
02/20/2008 |
|
Dear IRB: February 2008 |
02/20/2008 |
|
From the Auditor’s Desk – 2/08: Authorized Signatures and IRB Submissions |
02/20/2008 |
|
Arrested Enrollment: What Happens When Research Subjects are Incarcerated? – January 2008 |
01/17/2008 |
|
Things to Know: January 2008 |
01/17/2008 |
|
Congratulations: January 2008 |
01/17/2008 |
|
Dear IRB: January 2008 |
01/17/2008 |
|
From the Auditor’s Desk – 1/08: Understanding Protocol Exception Requests |
01/17/2008 |
|
New Options for Subject Recruitment – December 2007 |
12/18/2007 |
|
Things to Know: December 2007 |
12/18/2007 |
|
Congratulations: December 2007 |
12/18/2007 |
|
Dear IRB: December 2007 |
12/18/2007 |
|
From the Auditor’s Desk – 12/07: When should a subject be withdrawn from further study participation? |
12/18/2007 |
|
Unanticipated Problems and Adverse Events: Investigator Responsibilities – November 2007 |
11/28/2007 |
|
Things to Know: November 2007 |
11/28/2007 |
|
Congratulations: November 2007 |
11/28/2007 |
|
Dear IRB: November 2007 |
11/28/2007 |
|
From the Auditor’s Desk – 11/07: Have you been following your Data Safety Monitoring Plan ? |
11/28/2007 |
|
Reporting Unanticipated Problems to the IRB (Formerly SAE Reporting) – October 2007 |
10/24/2007 |
|
Things to Know: October 2007 |
10/24/2007 |
|
Congratulations: October 2007 |
10/24/2007 |
|
Dear IRB: October 2007 |
10/24/2007 |
|
From the Auditor’s Desk – 10/07: Translated Consent Forms – When Do You Need to Use One? |
10/24/2007 |
|
The Importance of Eligibility Criteria – September 2007 |
09/18/2007 |
|
Things to Know: September 2007 |
09/18/2007 |
|
Congratulations: September 2007 |
09/18/2007 |
|
Dear IRB: September 2007 |
09/18/2007 |
|
From the Auditor’s Desk – 9/07: The responsibilities of being a Principal Investigator |
09/18/2007 |
|
Things to Know: June 2007 |
06/27/2007 |
|
Congratulations: June 2007 |
06/27/2007 |
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Dear IRB: June 2007 |
06/27/2007 |
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From the Auditor’s Desk – 6/07: Documenting Adverse Events and Maintaining Source Documents |
06/27/2007 |
|
A Statistician Reflects on Fraud in Clinical Research – June 2007 |
06/27/2007 |
|
Things to Know: May 2007 |
05/24/2007 |
|
Congratulations: May 2007 |
05/24/2007 |
|
Dear IRB: May 2007 |
05/24/2007 |
|
From the Auditor’s Desk – 5/07: Avoid trouble with your sponsor |
05/24/2007 |
|
Beyond the Pregnancy Test: When Can Pregnant Women Participate in Research? – May 2007 |
05/24/2007 |
|
Things to Know: April 2007 |
04/23/2007 |
|
Congratulations: April 2007 |
04/23/2007 |
|
Dear IRB: April 2007 |
04/23/2007 |
|
From the Auditor’s Desk – 4/07: An Ounce of Prevention |
04/23/2007 |
|
The Certificate of Confidentiality – April 2007 |
04/23/2007 |
|
Clinical Research and the Rise in Litigation – March 2007 |
03/23/2007 |
|
Things to Know: March 2007 |
03/23/2007 |
|
Congratulations: March 2007 |
03/23/2007 |
|
Dear IRB: March 2007 |
03/23/2007 |
|
From the Auditor’s Desk – 3/07: Enrolling Subjects More Than Once |
03/23/2007 |
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Accessing Data for Clinical Research: The BMC Clinical Data Warehouse, a New Resource – February 2007 |
02/21/2007 |
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Things to Know: February 2007 |
02/21/2007 |
|
Congratulations: February 2007 |
02/21/2007 |
|
Dear IRB: February 2007 |
02/21/2007 |
|
From the Auditor’s Desk – 2/07: Submitting Protocol Deviations |
02/21/2007 |
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Banking–It’s Not Just for Money Any More: Tissue and Data Repositories – January 2007 |
01/26/2007 |
|
Things to Know: January 2007 |
01/26/2007 |
|
Congratulations: January 2007 |
01/26/2007 |
|
Dear IRB: January 2007 |
01/26/2007 |
|
From the Auditor’s Desk – 1/07: Storing Agents Used in Investigational Drug Protocols |
01/26/2007 |
|
Things to Know: December 2006 |
12/19/2006 |
|
Congratulations: December 2006 |
12/19/2006 |
|
Dear IRB: Decmber 2006 |
12/19/2006 |
|
From the Auditor’s Desk – 12/06: Using Approved Informed Consent Forms |
12/19/2006 |
|
Anatomy of a Research Record – December 2006 |
12/18/2006 |
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Planning for Data and Safety Monitoring in Clinical Research Studies – November 2006 |
11/29/2006 |
|
Things to Know Test: November 2006 |
11/29/2006 |
|
Congratulations: November 2006 |
11/29/2006 |
|
Dear IRB: November 2006 |
11/29/2006 |
|
From the Auditor’s Desk – 11/06: Obtaining Prospective Consent |
11/29/2006 |
|
Either You’re In or You’re Out! Screening Research Subjects – October 2006 |
10/26/2006 |
|
Things to Know: October 2006 |
10/26/2006 |
|
Congratulations: October 2006 |
10/26/2006 |
|
Dear IRB: October 2006 |
10/26/2006 |
|
On Rewarding Subjects – September 2006 |
09/21/2006 |
|
Things to Know: September 2006 |
09/21/2006 |
|
Congratulations: September 2006 |
09/21/2006 |
|
Dear IRB: September 2006 |
09/21/2006 |
|
Problems of Informed Consent and Low Literate Populations – June 2006 |
06/22/2006 |
|
Things to Know: June 2006 |
06/22/2006 |
|
Congratulations: June 2006 |
06/22/2006 |
|
Dear IRB: June 2006 |
06/22/2006 |
|
IRB Review: When is One Not Enough? – May 2006 |
05/26/2006 |
|
Things to know: May 2006 |
05/26/2006 |
|
Congratulation: May 2006 |
05/26/2006 |
|
Dear IRB: May 2006 |
05/26/2006 |
|
Dodging New Potholes on the Research Superhighway – April 2006 |
04/20/2006 |
|
Things to Know: April 2006 |
04/20/2006 |
|
Congratulations: April 2006 |
04/20/2006 |
|
Dear IRB: April 2006 |
04/20/2006 |
|
Data Analysis and the IRB: A Guide for BUMC Investigators – March 2006 |
03/22/2006 |
|
Things to Know: March 2006 |
03/22/2006 |
|
Congratulations: March 2006 |
03/22/2006 |
|
Dear IRB: March 2006 |
03/22/2006 |
|
Things to Know: February 2006 |
02/27/2006 |
|
Congratulations: February 2006 |
02/27/2006 |
|
Dear IRB: February 2006 |
02/27/2006 |
|
BUMC IRB Quality Assurance Reviews: What to Expect – February 2006 |
02/24/2006 |
|
Consenting Subjects – Looking for Answers – January 2006 |
01/23/2006 |
|
Things to Know: January 2006 |
01/23/2006 |
|
Congratulations: January 2006 |
01/23/2006 |
|
Dear IRB: January 2006 |
01/23/2006 |
|
HIPAA in Research: Reviewed, Revised, Revisited – December 2005 |
12/21/2005 |
|
Things to Know: December 2005 |
12/21/2005 |
|
Congratulations: December 2005 |
12/21/2005 |
|
Dear IRB: December 2005 |
12/21/2005 |
|
Dear IRB: November 2005 |
11/30/2005 |
|
When experimental treatment is not research: Emergency and Compassionate Use – November 2005 |
11/29/2005 |
|
Things to Know: November 2005 |
11/29/2005 |
|
Congratulations: November 2005 |
11/29/2005 |
|
If the Subject Can’t Consent, Then What? – October 2005 |
10/26/2005 |
|
Things to Know: October 2005 |
10/26/2005 |
|
Congratulations: October 2005 |
10/26/2005 |
|
Advertising and Recruitment Guidelines for Research Studies – September 2005 |
09/27/2005 |
|
Things to Know: September 2005 |
09/27/2005 |
|
Congratulations: September 2005 |
09/27/2005 |
|
Things to Know: June 2005 |
06/30/2005 |
|
Congratulations: June 2005 |
06/30/2005 |
|
Clinical Research Resources at BUMC: Services and Opportunities for Collaboration – June 2005 |
06/30/2005 |
|
Things to Know: May 2005 |
05/31/2005 |
|
Congratulations May 2005 |
05/31/2005 |
|
Are You “Engaged” in Research? The answer to this question determines if you need IRB approval – May 2005 |
05/31/2005 |
|
Things to Know: April 2005 |
05/01/2005 |
|
Congratulations April 2005 |
05/01/2005 |
|
Database Research: When is it Not Human Subject Research? When is it Exempt? When is it Expedited? – April 2005 |
04/29/2005 |
|
INVESTIGATOR RESPONSIBILITIES – March 2005 |
03/24/2005 |
|
Things to Know: March 2005 |
03/24/2005 |
|
Congratulations March 2005 |
03/24/2005 |
|
Demystifying Adverse Event Reporting – February 2005 |
02/28/2005 |
|
Things to Know: February 2005 |
02/28/2005 |
|
Congratulations: February 2005 |
02/28/2005 |
|
Clinical Research Without Informed Consent: How Can it be Legal? How Can it be Ethical? – January 2005 |
01/31/2005 |
|
Things to Know: January 2005 |
01/31/2005 |
|
Congratulations: January 2005 |
01/31/2005 |
|
Primer on Third Party Insurance Payment During the conduct of clinical Trials: What Researchers Need to Know – December 2004 |
12/17/2004 |
|
Things to Know: December 2004 |
12/17/2004 |
|
Congratulations: December 2004 |
12/17/2004 |
|
Research in Children: What Level of Risk is Acceptable? – November 2004 |
11/23/2004 |
|
Things to Know: November 2004 |
11/23/2004 |
|
Congratulations: November 2004 |
11/23/2004 |
|
Kickback Concerns in Clinical Research – October 2004 |
10/28/2004 |
|
Things to Know: October 2004 |
10/28/2004 |
|
Congratulations: October 2004 |
10/28/2004 |
|
Getting to “Yes”: A Look Inside the IRB Committee Process – September 2004 |
09/28/2004 |
|
Things to Know: September 2004 |
09/28/2004 |
|
Congratulations: September 2004 |
09/28/2004 |
|
Things to Know: June 2004 |
06/28/2004 |
|
Congratulations: June 2004 |
06/28/2004 |
|
Clinical Research: A Risky Business – June 2004 |
06/24/2004 |
|
PRIVACY AND CONFIDENTIALITY: IT?S MORE THAN HIPAA! – May 2004 |
05/13/2004 |
|
Things to Know: May 2004 |
05/13/2004 |
|
Congratulations: May 2004 |
05/13/2004 |
|
Expedited, Exempt, IRB Full Board? Determining the Type of IRB Review is Risky Business – April 2004 |
04/22/2004 |
|
Things to Know: April 2004 |
04/22/2004 |
|
Congratulations: April 2004 |
04/22/2004 |
|
INSPIR and Protection of Human Subjects – March 2004 |
03/25/2004 |
|
Things to Know: March 2004 |
03/25/2004 |
|
Congratulations: March 2004 |
03/25/2004 |
|
Scientific Review and the IRB – February 2004 |
02/25/2004 |
|
Things to Know: February 2004 |
02/25/2004 |
|
Congratulations: February 2004 |
02/25/2004 |
|
Continuing Review: What does the IRB Need? – January 2004 |
01/19/2004 |
|
Things to know: January 2004 |
01/19/2004 |
|
Congratulations: January 2004 |
01/19/2004 |
|
BUMC’s New Conflict of Interest Policy: What Investigators Need to Do Before December 31st – December 2003 |
12/16/2003 |
|
Things to know: December 2003 |
12/16/2003 |
|
Congratulations: December 2003 |
12/16/2003 |
|
Clinical Research Certification and Recertification at BUMC – November 2003 |
11/26/2003 |
|
Things to know: November 2003 |
11/26/2003 |
|
Congratulations: November 2003 |
11/26/2003 |