Quality Assurance

Implement an internal quality assurance program including routine self-audits, modification of existing Standard Operating Procedures (SOPs) or implementation of new SOPs for issues identified during the internal QA process, and implementation of programs of corrective action. Implement the use of electronic health records in conjunction with electronic case report forms to insure the accuracy of data collection.

Articles:

Resources:
Good Clinical Practice and Federal Code of Regulations, Rare Disease Clinical Research Network
This free online Seminar discusses topics that include GCP and Auditing and is produced by the Rare Diseases Clinical Research Network.

Computerized Systems Used in Clinical Trials, FDA
This guidance, published by the Food and Drug Administration, provides helpful oversight regarding use of electronic records in clinical research. Topics include; SOPs, Data Entry, System Features, Security, System Dependability/ Controls, Training Personnel, Record Inspection, and Electronic Signatures.

Centers for Devices and Radiological Health (CDRH), FDA
CDRH has produced and extensive list of free, online modules regarding the regulatory requirements associated with clinical research that incorporates device and radiology components. Over 20 modules are available, each including an online video presentation and posttest.

MAGI
MAGI is a membership organization with a mission to standardize best practices for regulatory compliance and clinical research operations. MAGI offers research conferences, certification, and access to templates free-of-charge online.

Online Educational Videos, OHRP
These online videos, developed by the Office of Human Research Protection (OHRP), cover topics including: “General Informed Consent Requirements,” “Institutional Review Board (IRB) Membership,” “Research Use of Human Biological Specimens and Other Private Information,” and “Reviewing and Reporting Unanticipated Problems and Adverse Events.”