Regulatory Landscape

Facilitating Understanding in Informed Consent

2024-04-11T17:22:49+00:00April 11th, 2024|Categories: Regulatory Landscape|

Have you read the draft guidance posted by FDA on Facilitating Understanding in Informed Consent? The key takeaway is that important information that would impact a participant’s decision on whether to participate in a trial should be presented at the beginning of the ICF process. FDA encourages the use of ‘bubbles’ to highlight key information, [...]

Assessing the potential impact of ICH E6 R3 on Electronic Health Records August 2023

2023-12-04T21:32:58+00:00December 4th, 2023|Categories: Regulatory Landscape|

Assessing the potential impact of ICH E6 R3 on Electronic Health Records (EHRs). Help is available! Section 4.3 of the draft guidance indicates that the sponsor should review whether the systems used by the investigator/institution (e.g., electronic health records and other record keeping systems for source data collection) are fit for purpose in the context [...]

2021 GCP Inspection Findings for Computer Systems

2023-01-10T17:12:27+00:00January 10th, 2023|Categories: Regulatory Landscape|

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 [...]

Contributor – The Future of Clinical Trial Design Looks Bright

2021-08-17T14:31:11+00:00August 17th, 2021|Categories: Regulatory Landscape|

Article published on the Applied Clinical Trials website on 12th August 2021 This article can be accessed at

Why All Eyes Should be on the RECOVERY Trial

2020-05-15T17:31:34+00:00May 15th, 2020|Categories: Regulatory Landscape|

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) [...]

Nothing about us without us

2020-05-15T17:38:16+00:00November 1st, 2019|Categories: Regulatory Landscape|

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 [...]

Keeping up with what is new in clinical research

2020-05-15T17:43:41+00:00September 26th, 2019|Categories: Regulatory Landscape|

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 [...]

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