Inspections and Audits

ARTICLES

Report Outlines Strategies for Risk-Based Monitoring

As centralized risk-based clinical trial monitoring becomes the norm, sponsors are gaining access to broad overview data on research and compliance trends that can help them identify both real and potential problems across their trial locations. Read More

Trial Investigator Warned Over Lack of SOP Documentation

A San Diego, Calif.-based clinical researcher received an FDA warning letter over its lack of documentation of standard operating procedures for overseeing studies and details of in-service protocol and specimen handling training in a Form 483 response. Read More

FDA Reduces Clinical Hold On Tekmira’s Ebola Drug

Canadian biotech company Tekmira is set to restart a Phase I trial of its TKM-Ebola RNA interference therapy in the coming weeks, after the FDA downgraded a partial clinical hold that allows the company to administer repeat doses not greater than 0.24 mg/kg/day. Read More

Expert: Clearly Define Roles Of the Central IRB

Clinical trial sites should determine their compatibility with central institutional review boards, including whether software they use to interface with the local IRB is capable of handling an outside review board, an expert says. Read More

PRODUCTS

ICH E6 R2 - Webinar Recording/Transcript

$287.00
The ICH E6 R2 GCP guideline has major impact on everyone from clinical trial principal investigators to drug and biologics makers. But a year after its promulgation, clinical trials professionals still struggle with its provisions. View

Managing FDA GCP/Bioresearch Monitoring Inspections - Webinar Recording/Transcript

$287.00
Clinical trial principal investigators and sponsors have their very own dedicated team of FDA inspectors, the Bioresearch Monitoring (BIMO) program staff. Washington public policy lawyer, David Rosen, has made a study of their inspection practices. View

GCP Qualification Audits: Choosing Quality Contractors and Sites

$397.00
In GCP Qualification Audits, Ms. Sceppa lays out her approach to evaluating and selecting the best, most compliant and highest quality contractors to give your trial the best shot at success. View

Clinical Trials Adverse Event Reporting Guide, 2017 Edition

$397.00
You’ll find the answers to those questions and many more in the 2017 edition of Clinical Trials Adverse Event Reporting Guide. View

ClinicalTrials.gov: Mastering New Reporting Rules

$397.00
ClinicalTrials.gov: Mastering New Reporting Rules parses out the rules provisions, explaining who must report what — what information they must submit — what deadlines are — and what could happen if they miss the mark. View

Global Regulation Under Gottlieb-Trump and a Look Ahead - Webinar Recording/Transcript

$287.00
In Part IV of FDAnews’s Expert Insight Series, our panelists look overseas to evaluate drug and device regulation globally, and venture educated guesses concerning the direction of drug and device regulation in 2018 and beyond. View

Pharmaceutical Regulation Under Gottlieb-Trump - Webinar Recording/Transcript

$287.00
In Part III of FDAnews’s Expert Insight Series, our panel takes up drug regulation, policy and enforcement. View

Device Regulation Under Gottlieb & Trump - Webinar Recording/Transcript

$287.00
In Part II of FDAnews’s Expert Insight Series, our panel dives deep into device regulation, policy and enforcement. View

What We’ve Learned Since Scott Gottlieb Was Confirmed - Webinar Recording/Transcript

$287.00
FDAnews has assembled a standout panel — five top experts, four of them ex-FDAers — to bring their insights to bear on how the Gottlieb FDA will impact your products and programs. View

FDA’s Work Plan ... the 21st Century Cures Act ... and You - Webinar CD/Transcript

$287.00
The 21st Century Cures Act is a mega-complex set of compromises that Congress mandated. Right now, behind closed doors, the FDA is figuring out how to implement it. Every FDA-regulated health sciences company will be affected. View

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