CenterWatch Announces GCP Questions, FDA Answers, 2021 Edition

What are the penalties for not complying with ClinicalTrials.gov reporting procedures?
How should ongoing training efforts be documented?\nIt can only help to learn from questions others have already asked.\nThrough 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.
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.\nGet answers and ensure trial success with GCP Questions, FDA Answers, 2021 Edition.\n'

FALLS CHURCH, Va., May 13, 2021 /PRNewswire-PRWeb/ -- GCP Questions, FDA Answers, 2021 Edition
A CenterWatch Book
https://www.centerwatch.com/products/category/1105-books/product/535-gcp-questions-fda-answers-2021-edition

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.

Book Details:
GCP Questions, FDA Answers, 2021 Edition
A CenterWatch Book
https://www.centerwatch.com/products/category/1105-books/product/535-gcp-questions-fda-answers-2021-edition

Price:
$397

Easy Ways to Purchase:
Online: https://www.centerwatch.com/products/category/1105-books/product/535-gcp-questions-fda-answers-2021-edition
By phone: 888.838.5578 or 703.538.7600

About CenterWatch:
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.

Media Contact

Michelle Butler, CenterWatch, 703.538.7600, [email protected]

SOURCE CenterWatch