Facilitating Understanding in Informed Consent

By |April 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Have you read the draft guidance posted by FDA on Facilitating Understanding in Informed Consent?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, bullet points and white space for this summary of key information with reference (links or page numbers) to where additional information is located in the ICF document. An example of a Key Information Section is provided as an Appendix to the guidance. They also recommend use of plain language principles for the entire consent form. Plain language is clear, concise, organized, and appropriate for the intended audience. The 10 Top Principles for Plain Language as per the National Archives are: Write for your reader, not yourself. State your major points first before going into [...]

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

By |December 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 Section 4.3 of the draft guidance indicates that the sponsor should review whether the systems used by the investigator/institution (e.g., electronic health records and other record keeping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 of the trial. Other expectations include (not an exhaustive list): The responsible party (i.e., the investigator) should ensure that security controls are maintained for computerised systems. These controls should include user management and ongoing measures to prevent, detect and/or mitigate security breaches. Aspects such as user authentication requirements and password management, firewall settings, antivirus software, security patching, system monitoring and penetration testing should be considered. The responsible party (i.e., the investigator) should maintain adequate backup of the data. Procedures should cover the following: system security measures, data backup and disaster recovery. The responsible party [...]

2021 GCP Inspection Findings for Computer Systems

By |January 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 am going to focus on those findings in this post.Audit Trails and Authorized Access:Lack of procedure for period review of user accesses.Lack of audit trail to reconstruct the course of events.Deficiencies in/ late provision of access to electronic systems for relevant team members (PI, monitors)Computer Validation:Lack of risk assessment of the computer system.Lack of procedure for validation of computerised systems.Lack of testing documentation and conduct.Physical Security System and Backup:Security issues for the remote internet access to the system (no encrypted channel).Lack of periodic reviews of firewalls protecting the system.Lack of record of security incidents.Lack [...]

Contributor – The Future of Clinical Trial Design Looks Bright

By |August 17th, 2021|Categories: Regulatory Landscape|

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

What’s New

By |July 6th, 2021|Categories: Regulatory Landscape|

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 it to you if you wish. It certainly is comprehensive. It replaces the reflection paper on expectations for electronic source data issued in 2010 and addresses among other things cloud solutions, eConsent, Contracts, Computer Systems validation, User Management and security and requirements related to specific types of systems like IRT and ePRO. The expectations for both Sponsors and Investigators are greater. For example, the guideline recommends that an Investigator receive an introduction on how to navigate audit trails of their own data so that they can review changes made. Risk-based audit trail review, focused [...]

Peer Reviewed – Quality by Design in the RECOVERY Trial (Randomized Evaluation of COVID-19 Therapy)

By |December 15th, 2020|Categories: Oriel Research Services|

Article published on the The Association of Clinical Research Professionals (ACRP) website on 15th December 2020 This article can be accessed at

Why All Eyes Should be on the RECOVERY Trial

By |May 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) and the Ethics Committee (IRB) on March 13th. It received regulatory approval on March 16th and IRB approval on March 18th. The first patient was enrolled on March 19th. By April 1st, 1000 patients had been enrolled. The study Sponsor is the University of Oxford and it is being funded by UK Research and Innovation/ National Institute of Health Research. In line with quality by design principles, all trial processes are greatly streamlined. The main outcomes are death, discharge, the need for ventilation and the need for renal replacement therapy. The ICF is simple [...]

Nothing about us without us

By |November 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 spelling out the ‘Quality by Design’ concept and identifying ‘Critical to Quality’ factors. The three take-aways for me were: 1. Stakeholder engagement. Dr. Buse, Division Chief and Director of the Diabetes Center at UNC, said clinician input is essential and that language in guidance should be more forceful. Sponsors should ‘pare down’ the burden they put on patients. John Adams, Best Medicines Coalition of Canada, said patients want to be at the table. They are not subjects, but participants or partners. ‘But are we junior partners or equal partners?’ ‘Patients should be treated with [...]

Keeping up with what is new in clinical research

By |September 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 to patients. Patient centricity has been a buzzword for some time, but it is now called out in a guidance document. There is a whole section devoted to Designing Quality into Clinical Trials which calls for focusing on critical to quality factors that are aligned with a proactive approach. Some of the language is a little vague and could be open to interpretation by inspectors. I am looking forward to the final document. Currently 5 entities have submitted comments to FDA and those comments can be located at The expectation is that it [...]

Experience and qualifications of the research coordinator – why it matters

By |August 7th, 2019|Categories: Monitoring|

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 maintains study records.’ No kidding! The experience and qualifications of the research coordinator should be evaluated when selecting the site for study participation. How long have they been in their current role? What about the length of time in their prior roles? Generally, people stay in jobs longer if they have good relationships with their peers. Does their CV have typos and grammatical errors? This might suggest a lack of attention to detail. Are they a member of the Association of Clinical Research Professionals (ACRP)? Are they a certified clinical research coordinator (CCRC)? Membership [...]

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