Minutes of the GCP Consultative Committee Meeting 22 September 2011
MHRA, R-T-310, 3rd Floor, 151 Buckingham Palace Rd, London, SW1W 9SZ
External Attendees:
Alec Deighton ACRO
Barney Horne BARQA
Carol Wilcock ABPI Clinical Research Expert Network (CREN)
Colin Wilsher BARQA
Dave Walpole Association of Clinical Data Managers (ACDM)
David Neal NRES
Gary Roper Brunswick Group
Gill Booth UK CRN
Heather House University of Oxford
Jackie Pullen Joint Clinical Trials Office, Guys Hospital
Jacqueline Mathews NIHR
John Poland ACRO
Liz Tremain NETSCC
Malcolm Boyce AHPPI
Mandy Wan NHS Pharmacists
Megan Heath CREN
Paul Carlin NI NHS
Paul Strickland Bioindustry Association (BIA)
Paul Wathall Institute of Clinical Research
Rachel Partridge CR UK & UCL Cancer Trials Centre
Richard Redhead ABPI
External Attendees via TC:
Angela Ball NHS R&D Forum
Dr Caroline Watson Scottish Government
Mike Stevens Scottish Government
MHRA Attendees:
Vincent Yeung (CHAIR) Senior GCP Inspector and GCP Operations Manager
Gail Francis Expert GCP Inspector, MHRA
Martyn Ward Clinical Trials Unit
Bernadette Sinclair-Jenkins Licensing and Regulatory Advice Unit Manager
Andrew Fisher Senior GCP Inspector
Kath Meely Senior GCP Inspector
Sue Berens GCP Inspector
Amy Stock GCP Inspector
Apologies:
Rebecca Stanbrook Group Manager, Inspections, GCP,/GLP/PV
Gerald Heddell Director I, E & S, MHRA
Alan Irvine ABPI Clinical Research Expert Network (CREN)
Ali Zaatar Institute of Clinical Research
Angela Hallam National Assembly Gov. Wales
Janette Benaddi Institute of Clinical Research
Jenny Lamport TOPRA
Marc Taylor DOH
Mark Howells NHS Pharmacists
Paul Biagioni NI NHS
Rob Nichols Association of Clinical Data Managers (ACDM)
Sarah Meredith Medical Research Council
1 Welcome
1.1 VY welcomed everyone to the GCP Consultative Committee meeting.
1.2 Apologies were presented for those unable to attend.
1.3 The minutes of the previous meeting (1st February 2011) were reviewed and agreed.
Comment on previous minutes: DN (NRES) provided an update that Ethics Committee guidance has now been revised to reflect the CT1 & CT3, with SOPs coming into effect on 01 Sep 2011.
Actions and updates from previous minutes:
Action / UpdateThere should not be separate general and technical meetings, as even the general meeting has some technical component. / To be taken forward - Each meeting will be a combined general and technical meeting.
Meetings should include presentations from the external organisations attending the meeting. / To be taken forward. JP (ACRO) presented at this meeting – see Item 4.
The MHRA continues to welcome this idea and asks external organisations to submit any ideas they would like to present to SB (MHRA).
MHRA presentation slides should be disseminated on the day of the meeting or soon afterwards. / To be taken forward. Presentation slides for this meeting circulated on 23 September 2011.
Q&A to be disseminated before the meeting. (Reliant on the attendees submitting the questions by the pre-specified deadline, to ensure that the MHRA has sufficient time to draft a response.) / To be taken forward. Q&A for this meeting circulated on 20 September 2011.
The meeting minutes, Q&A and presentation slides should be made available on the MHRA website to facilitate the dissemination of information. / General discussion regarding the rationale for this. VY (MHRA) agreed to review the most appropriate place to publish this information on the website. ACTION.
GCP team to feed back re: Inspection feedback at the next meeting in September 2011. / Provided – see Item 3.
Organisations who have not already appointed a deputy, to provide relevant deputy contact details. / Ongoing – send to SB (MHRA)
2 GCP Inspectorate Update (Vincent Yeung, Senior GCP Inspector and GCP Operations Manager)
VY presented an update on the GCP Inspectorate covering recent staff changes, GCP team interactions with stakeholders and other agencies, legislative changes and other developments such as Risk Adaptation and the GCP Forum. See slides 1 to 9 of the attachment in section 9.
In relation to the presentation, BH (BARQA) asked if contributors on the GCP forum would be anonymous. VY (MHRA) responded that this would be possible – it is being proposed (during the development process) that as part of registering to use the forum, users would select a user name and this user name is what would appear next to the individual’s contribution on the forum.
VY (MHRA) further clarified that the GCP forum should not be used for questions directed to the GCP inspectorate, notification of serious breaches or complaints - as formal routes are already in place to deal with these types of communication. The primary focus of the forum will be to allow organisations and individuals to discuss and share best practice.
CW (BARQA) asked whether risk adaption during the conduct of the inspection would be considered i.e. inspectors would select only parts of the TMF they needed to be supplied with on inspection. AF (MHRA) responded that this would not be the case as the whole TMF would still need to be made readily available to the inspector in order to assess the quality and compliance of the conduct of the trial. AF clarified that the method by which parts of the TMF could be provided (i.e. paper, electronically, on request), can be agreed with the inspector during the planning stage of the inspection.
3 Inspection Feedback – Results of Questionnaires (Vincent Yeung, Senior GCP Inspector and GCP Operations Manager)
VY (MHRA) presented on the outcome of the inspection questionnaires sent out in May 2011 to 40 organisations inspected by GCP inspectors: It was found that the feedback was predominantly positive however areas of improvement were identified. The GCP inspectorate will respond by revising the SCTS guidance/request form and revising the content/layout of the GCP website and pre-inspection letter template. See slides 10 to 22 of the attachment in section 9.
In relation to the presentation, AD (ACRO) asked if those organisations who did not respond positively were associated with poor inspection outcomes. VY (MHRA) clarified that it was not possible to determine this as responses to the questionnaires were handled confidentially by the I E & S Quality Manager and data were anonymised prior to issue to the inspectorate.
JP (JCTO, Guy’s) suggested that inspectors could provide feedback (as required) to organisations on the content of their dossiers during the inspection preparation process. PS (BIA) further suggested that a request for information in the dossier should be accompanied with a rationale why it is being asked for. This would reduce organisations being overcautious and sending in too much, unnecessary information. VY (MHRA) agreed these would be good approaches and they would be considered. ACTION.
4 ACRO Study: Preliminary Look at the Quality of Clinical Trials Data across Regions (John Poland, ACRO)
JP (ACRO) presented on the study conducted by his organisation to determine if market maturity in various regions of the world impacts the quality of clinical research data generated in support of FDA and EMA marketing authorisation applications, as measured by data base query rates. Details of a follow-up Site Quality Study which was in the process of being conducted were also provided. See slides 23 to 52 of the attachment in section 9.
With regards to the follow up study there were several clarifications sought. JP (ACRO) responded as follows: Entry deviations would not be separated out from other protocol deviations; different regional approaches to protocol waivers would not be taken into account; the number of SAE reports would be the number supplied to the sponsor; Audit findings would include results from audits and inspections.
5 Risk adapted approach to trial monitoring (Andy Fisher, Senior GCP Inspector)
AF presented an update on the Risk Adaptive Approach to clinical trials and provided an
overview of the setting up of a collaborative group to assist with further advice for, firstly, risk assessments and monitoring plans. The group will include non-commercial and commercial sponsors and will result in the development of FAQs/Guidance for MHRA GCP Forum as well as example documents for others to use. The launch of the sub group would be held later that day.
See slides 53 to 58 of the attachment in section 9.
6 General GCP Inspections Questions and Answers
See section 10 attached.
For question 4, JM (NIHR) added that it was important to be clear that the NIHR process only applies to studies that received their initial approval via NIHR CSP. For studies outside this remit, the Sponsor will need to liaise with individual NHS organisation and processing times are determined locally.
7 AOB
a) KM (MHRA) provided an update on the GCP Guide and explained that a summary/outline of each chapter will be made available on the MHRA website once the chapters have been adequately reviewed. KM confirmed the GCP Guide will only be made available in hardcopy. See slides 59 to 61 of the attachment in section 9.
b) VY (MHRA) informed everyone that the next GCP Consultative Committee will be held on 28 February 2011 (10:00 -12.30, MHRA, R-T-502, 5th Floor, 151 Buckingham Palace Rd, London, SW1W 9SZ). VY (MHRA) thanked all those who attended the meeting.
8 Summary of Action Points
Action: Review the most appropriate place to publish meeting minutes, Q&A and presentation slides on the MHRA website
Action: Inspectors to provide feedback (as required) to organisations on the content of their dossiers during the inspection preparation process.
Action: Consider the following for inclusion in the dossier/related guidance- a request for information in the dossier should be accompanied with a rationale why it is being asked for.
9 Presentation slides from meeting
10 Questions Raised for GCP Consultative Committee Meeting AND Answers
GCP CC Meeting Minutes 22 September 2011
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