Clinical Trials Adverse Event Reporting Guide, 2020 Edition
The FDA is constantly changing its rules for protecting trial participants, especially when it comes to reporting adverse events.
Are you up to speed on the latest developments — from ICH E6(R2) to the recently revised Common Rule — that could affect your clinical trial’s reporting procedures? Do you know enough to build and maintain a compliant system?
Get a comprehensive overview with CenterWatch’s Clinical Trials Adverse Event Reporting Guide, which covers more than 20 guidances from the FDA, HHS and the ICH and includes the text of all regulations pertaining to reporting adverse events in clinical trial.
Purchase this guide for a timely overview of key issues such as:
- Assessing how to report adverse events to your IRB
- Determining how to establish and operate a clinical trial data monitoring committee
- Identifying how to observe patients in gene therapy trials for delayed adverse events
- Critically evaluating how to report incidents to the HHS Office of Human Research Subject Protections
- Handling unanticipated problems involving risks and adverse events
New in the 2020 edition
- ICH E6(R2) — guideline on good clinical practice
- ICH E3 — guideline on structure and content of clinical study reports
- FDA guidance on Providing Regulatory Submissions in Electronic Format: IND Safety Reports and its technical conformance guide
- FDA specifications for preparing and submitting electronic individual case study reports (ICSRs) and ICSRs attachments
- Working draft of the upcoming ICH E19 guideline on optimization of safety data collection
- Revised Common Rule
This new edition is a must-have, go-to guide for clinical trial compliance. Order your copy today.
Who will benefit?
- Drug and device trial sponsors
- Trial site organizations
- Academic research centers
- Hospitals and private practices conducting clinical trials
- Regulatory compliance officers
- IRB members
- Trial managers and investigators
- Directors of research and clinical operations
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Not satisfied with your publication? For the PDF version, you must notify CenterWatch within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.