Warning Letters are on the rise, and can be issued to any entity or individual involved in a clinical study, including sponsors, clinical trial monitors, investigators (including other site personnel), IRBs, and clinical research organizations. This unique guide begins with the framework of Warning Letters, laying out a course to learn from others’ mistakes. Readers can expect guidance on understanding current trends in Warning Letters, avoiding Warning Letters, and responding to a Warning Letter if necessary.
This reference guide provides examples of key Warning Letters of pharmaceutical, drug, biologic, and device products, including:
- Failure to establish quality procedures, corrective and preventive action plans, and complaints records.
- Failure to maintain distribution records of investigational products.
- Failure to select qualified investigators.
- Failure to provide information to investigators needed to conduct the study properly.
- Failure to follow the protocol for recruiting subjects and following specified inclusion criteria.
- Failure to ensure each study is conducted in conformance to the study plan and protocol.
- Failure to maintain appropriate and accurate case histories of investigational observations.
- Failure to properly monitor a clinical investigation.
- Inadequate reporting of adverse events to the sponsor or IRB.
- Inadequate medical device accountability.
- Failure to maintain documentation of finished device acceptance to ensure that each finished batch of devices meets the acceptance criteria.
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