Guidance
Apr 17, 2012

Test Articles in Research

The term “ test article ” is found in the FDA regulations on Protection of Human Subjects ( 21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals , and gene therapy, and genetically derived products that meet the...
Guidance
Mar 12, 2012

Study-Specific AE Reporting

Click to review previous steps Step 1 Step 2 Refer to the IRB - approved documents for the specific study that includes a detailed plan for AE reporting . Follow the directions in the plan for reporting to oversight bodies (e.g. DSMB , sponsor, IRB...
Guidance
Mar 6, 2012

Accessing Medical Records

When requesting records the requestor must be listed on the approved IRB, provide the IRB# and approval letter. Medical record requests for research /review will be imaged and viewable in CareWeb . Health Information Management will generally image...
Guidance
Jun 17, 2011

AHRQ: Mandatory Use of Data Safety and Monitoring Plans

The Agency for Healthcare Research and Quality ( AHRQ ) has issued notice requiring Data Safety and Monitoring Plans (DSMPs) for certain AHRQ-conducted or -supported projects. As of May 6, 2011, the inclusion of DSMPs will be considered pa of...
Guidance
Jan 3, 2008

Record Keeping Guidelines

Investigators frequently ask how long they should keep research records after a study has ended. Because different regulations apply to different types of studies there is not a simple answer to this question. Ten years is a safe default standard,...
Guidance
Sep 5, 2005

Research and Non-English Speaking or Reading Subjects

Many patients at the University of Michigan Health System do not speak English or lack the fluency to understand medical and scientific information presented in English. In order for such a patient to participate in a research study, steps must be...

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