The 2021 Annual Report from the GCP Inspectors Working Group was posted on 21 November, 2022. It always makes for interesting reading. Due to Covid, only triggered inspections were conducted in 2021.There was an increase in CRO inspections compared to the previous report. Also of note was an increase in findings related to computer systems! I [...]
Article published on the Applied Clinical Trials website on 12th August 2021 This article can be accessed at https://www.appliedclinicaltrialsonline.com/view/the-future-of-clinical-trial-design-looks-bright
A draft guideline on computerized systems and electronic data in clinical trials! It was issued on Friday, June 18th. It is a 47- page pdf which you can access by visiting the EMA website, clicking on News & Events and then the ‘What’s new’ link and scrolling down to June 18th. I can also e-mail [...]
Article published on the The Association of Clinical Research Professionals (ACRP) website on 15th December 2020 This article can be accessed at https://acrpnet.org/2020/12/15/quality-by-design-in-the-recovery-trial-randomized-evaluation-of-covid-19-therapy/
It is the worlds largest randomized clinical trial of potential coronavirus treatments. As of this morning (Friday May 8th), 9418 participants have been randomized at 173 sites in the UK. What is even more astounding is that the first draft of the protocol was March 10th. It was submitted to both the Regulatory authorities (MHRA) [...]
That was the rallying cry from both investigators and patients at a public meeting on ICH E8 R1, General Considerations for Clinical Studies, held at FDA yesterday. I joined a Webex of the proceedings at different points during the day. The changes to the guideline are significant. It promotes fit for purpose clinical trials by [...]
There is so much… E8 R1-General Considerations for Clinical Trials has been released for public comment. Generally, I like the changes. Like E6 R2, quality is emphasized but the biggest change is the requirements for patient and treating physician input on the design of the clinical study and the selection of endpoints that are meaningful [...]
The recent draft guidance on Risk Based Monitoring (RBM) suggests that sponsors consider this when determining the timing, types, frequency and extent of monitoring activities. ‘The research coordinator serves an important role in ensuring the quality of the investigation at the investigative site…. the research coordinator often recruits subjects, collects and evaluates study data, and [...]
This is a no-brainer! You can ensure early in the enrolment phase that procedures are being done correctly. If not, a CAPA can be implemented sooner. The recently issued FDA draft guidance on Risk Based Monitoring (RBM) extols the benefit of an early monitoring visit or other early monitoring activities when determining the timing, types, [...]
Location where subjects will be seen: a factor to consider in monitoring activities The recently issued draft guidance recommends that the location where subjects will be seen (and how the data will be collected) relative to where sponsor oversight activities will be conducted, should be a factor you consider when determining the timing, types, frequency [...]
