E19: a selective approach to safety data collection in specific late-stage preapproval or post-approval clinical trials : guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Drug Evaluation and Research (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, December 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Clinical Trials as Topic Data Collection Government Regulation Patient Safety United States United States. Food and Drug Administration
- Genre(s):
- Guideline Technical Report
- Abstract:
- This guidance is intended to provide internationally harmonized guidance on the use of selective safety data collection that may be applied in specific pre-approval or post-approval late-stage clinical trials. Selective safety data collection refers to the reduced collection of certain types of data in a clinical trial after thorough consideration of factors that would justify such an approach. By tailoring the method and streamlining the approach to safety data collection, it may be possible to carry out clinical trials with greater efficiency. This may facilitate the conduct of large-scale efficacy and safety clinical trials with large numbers of participants and long-term follow-up. In all circumstances in which the use of selective safety data collection is considered, it is important that the welfare of every trial participant is safeguarded. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (4, 13 pages))
- NLM Unique ID:
- 9918590085706676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918590085706676