GCP

ARTICLES

Clinical Trial Questions: FDA’s Answers

The FDA provides all the GCP regulations and guidances you need to run a clinical trial, but those documents can’t answer every question you may have. Fortunately, the agency offers another resource — the staff of its Office of Good Clinical Practices. Every day, OGCP fields questions from investigators, sponsors, IRBs and other interested parties. Read More

Strategies to Reduce Inefficiency of GCP Training

How much training do clinical investigators and clinical study staff need to stay up to date on good clinical practices, particularly to ensure compliance for multiregional clinical trials? In a recent study, the Clinical Trials Transformation Initiative evaluated the content, frequency, format and enrollment evidence of GCP training and provided recommendations to improve the efficiency of GCP training. Jonathan Seltzer, the director of clinical research at the Lankenau Heart Institute and a co-author of the study, “Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency,” talks with CTA about the findings. Read More

How Diverse Are Clinical Trials?

A lack of diversity in clinical studies can have crucial health implications in minority populations, as medicines are launched with little understanding of genetic interactions, researchers and regulators warn. Read More

PRODUCTS

ClinicalTrials.gov and the New Final Rule (42 CFR Part 11) - Webinar CD/Transcript

$287.00
After reading and re-reading the 177 pages of 42 CFR Part 11, “Final Rule for Clinical Trials Registration and Results Information,” many trial operators are scratching their heads. Scott Cunningham Esq., translates the knottiest provisions of the final regulation into simple English. View

Spreadsheet Validation 2017 - Webinar CD/Transcript

$287.00
What if you could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he highlights potential pitfalls and defines innovative validation approaches ... ask why he does this instead of that ... and get feedback? View

Good Clinical Practices: The New ICH E6 Standard

$397.00
Good Clinical Practices: The New ICH E6 Standard outlines the changes in the guideline and offers suggestions for implementing new requirements. View

Internal Auditing Basics: A Guide for Drug and Device Manufacturers

$177.00
Internal Auditing Basics: A Guide for Drug and Device Manufacturers demonstrates how to build an auditing operation, including scheduling and reporting, explains regulatory requirements and discusses how to turn audit results into positive improvements. View

ICH E6 GCP Revisions - Webinar CD/Transcript

$287.00
Every clinical trial operator will feel the impact of the major revision of the ICH E6. The revision, known as ICH E6 (R2) GCP, will impose new requirements to use state-of-the-art technology ... force changes in trial design, conduct, oversight, recording and reporting ... and all the while, continue insisting on highest standards of human protection and data integrity. View

The FDA Under a New Commissioner - Webinar CD/Transcript

$287.00
Likely new FDA Commissioner Scott Gottlieb is an old agency hand thrust into a new role. Will he toe the Trump line ... or show independence? Is his past a guide ... or will he strike out in new directions? Will he ease new drug and device approvals ... or toughen them? Increase inspections ... or ease off? More 483s and warning letters ... or fewer? View

Three-Volume Clinical Trials Title 21 CFR Set 2017

$210.00
The federal government has compiled the new 2017 CFR volumes. View

Nine-Volume Title 21 CFR Set 2017

$585.00
The federal government has compiled the new 2017 CFR volumes.






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Clinical Research Manual

$380.00
Clinical Research Manual brings together guidance on everything from pharmacokinetics and study design, to recruitment, monitoring, statistics… all the problem compliance areas you need to stay on top of to conduct clinical trials that will stand up to regulatory scrutiny. View

Medical Device Clinical Evaluation Reports - Webinar CD/Transcript

$287.00
Michelle McDonough — Associate Director, Regulatory and Clinical Affairs, MCRA — discusses the requirements for CERs and their place in supporting new device certification and maintaining certification. She will cover best practices for completing CERs, complying with regulations including the MEDDEV 27/1 Rev 4 guidance. View

Combination Products and Cross-Center Reviews - Webinar CD/Transcript

$287.00
Mapping out a regulatory pathway for drug/device/biologic combination products remains one of the most difficult regulatory challenges for life sciences innovators. Join David M. Fox — Partner, Hogan Lovells — for a close look at the FDA’s new authority governing combination products and several new provisions under the 21st Century Cures Act that could usher in a new era of interdisciplinary product reviews at the FDA. View

Clinical Trial Compliance Guide: FDA Requirements

$397.00
The FDA has issued more than 100 guidance documents relating to clinical trials covering topics from the Animal Rule to validating software used in studies. If you had to pull all of them together yourself — and get the right version — it would take you hours. View