FALLS CHURCH, Va., May 13, 2021 /PRNewswire-PRWeb/ — GCP Questions, FDA Answers, 2021 Edition
A CenterWatch Book
What constitutes a “certified copy” of an electronic record? What are the penalties for not complying with ClinicalTrials.gov reporting procedures? How should ongoing training efforts be documented?
These are a few of the questions clinical research professionals have asked the Office of Good Clinical Practice (OGCP).
It can only help to learn from questions others have already asked.
Through this compilation of more than 100 questions and responses, GCP Questions, FDA Answers provides answers to questions about the many guidelines from the FDA, including those related to adverse events, investigator responsibilities, electronic medical records and data privacy protection. Find advice on some of the most difficult and important topics that you will face, along with documents and resources that will bring clarity to your practices.
This book will provide answers to the following:
- What constitutes a “certified copy” of an electronic record
- The site investigator’s responsibilities in reviewing IND safety reports originating from another study site
- How to assess and report adverse event causality
- Requirements for waiver or alteration of informed consent for pediatric trials
- How to get consent for nonEnglish-speaking subjects
- Criteria for IRB disapproval of a new study
- How to document ongoing training efforts
- Differences between good clinical practice training and human research subject protection training
- Penalties for not complying with ClinicalTrials.gov reporting requirements
- Requirements for investigator-initiated trials
- Considerations in protocol version control
- Transferring an IND to a new sponsor
- Sharing redacted files with a CRA via email or electronic upload
- Managing, dispensing and administering investigational products
Guidelines and regulations from the FDA are always evolving. But one can better understand the many changes that have occurred with this book. Learn from the many responses other professionals have received and ensure you are prepared to keep the trial on track.
Get answers — and ensure trial success — with GCP Questions, FDA Answers, 2021 Edition.
GCP Questions, FDA Answers, 2021 Edition
A CenterWatch Book
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Founded in 1994, CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. CenterWatch provides proprietary data and information analysis on clinical trials through a variety of newsletters, books, databases, and information services used by pharmaceutical and biotechnology companies, CROs, SMOs, and investigative sites involved in the management and conduct of clinical trials. As a pioneer in publishing clinical trials information, CenterWatch was the first Internet site to publish detailed information about active clinical trials that could be accessed by patients and their advocates.