Sponsors are required to ensure that trials are adequately monitored (ICH GCP 3.18.3). Proper monitoring is necessary to assure adequate protection of the rights of human subjects and the safety of all subjects involved in clinical investigations and the quality and integrity of the resulting data submitted.
The objectives of FEAST monitoring procedures are:
• To ensure that the trial is being carried out in accordance with the approved protocol.
• To identify any problems and suggest / seek solutions.
Above all the site monitor should be seen (and behave) as a supportive extension of the trial team. They have a professional duty to be impartial and their role is to ‘monitor’. However, it is ‘monitor’ and not ‘audit’ and therefore they should never be perceived as an outside threat but part of the team and there to guide and support the site, in particular the site coordinator. If they find any issues this should help everyone and they can help recommend a solution.
2. DEFINITIONS & ABBREVIATIONS:
• MONITORING: The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOPs, Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
• TRIAL MASTER FILE (TMF): Is the sites repository for the essential documents for the conduct of a clinical trial. These documents individually and collectively permit evaluation of the conduct of the trial and the quality of the data produced. These documents demonstrate the compliance of the sponsor-investigator and monitor with standards of GCP and with all applicable regulatory requirements.
• CASE REPORT FORMS (CRFs): A printed, optical or electronic document designed to record all of the protocol required information on each subject to be reported to the sponsor or for use in data analysis.
• SOP (Standard Operating Procedure): A document that provides a description of the established steps, methods or actions to describe the responsibilities pertaining to a routine process. These differ from studies or protocols that are used in non- routine processes.
3. WHO IS RESPONSIBLE FOR FEAST TRIAL MONITORING
The Clinical Trial Facility (CTF) within the Kemri-Wellcome programme in Kilifi will manage and coordinate the monitoring of FEAST. The CTF is an entity within the programme in Kilifi that manages the conduct and quality of Trials. The CTF has its own internal monitoring standards, training and procedures and is thereby able to take on the role of monitor for this trial as it is distinct from the trial team in Kilifi. The CTF will also refer to the MRC Clinical Trials Unit i(MRC CTU) for oversight. The MRC CTU will provide an assessment and validation of the trial monitoring both before and during the trial to confirm it is being conducted impartially, to an appropriate level of detail and to an appropriate standard. An MRC CTU monitor will come soon after study start and then at agreed periods there after.
A qualified monitor has been recruited for Uganda, they will be trained in Kilifi and they will report into the FEAST project manager in the CTF in Kilifi. They will be based in the Malaria Consortium Africa (MCA) in Kampala, Uganda and so will also have an operation reporting line within MCA. This monitor will be responsible for monitoring all the Ugandan sites, although will be assisted as needed (i.e. before an interim analysis or at database close) by the Kilifi team and with ultimate oversite from the MRC CTU. The Kilifi and Tanzanian sites will be placed on the CTF monitoring system and be monitored by the dedicated FEAST monitor.
4. FEAST TRIAL MONITORING TEAM
The trial is to run across 6 sites, 4 in Uganda, 1 in Tanzania and 1 in Kenya. Three main people will be involved in the monitoring: Ugandan site monitor (based at the Malaria Consortium Africa in Kampala), a Kenya/Tanzania site (KEMRI) monitor (based in Kilifi) who will coordinate monitoring of all the sites, and a MRC monitor who will have oversight over the trial monitoring activities. The Kenyan based monitor might need to support the Ugandan monitor on occasion. This will be determined by the TMT i The project manager will manage the 2 site monitors and arrange to have them accompanied on visits where necessary – this might be by members of the TMG or other CTF monitors as within the CTF there is also wider support for the FEAST trial monitoring as this plan will fit into the overall CTF’s monitoring programme. As needed it will be possible to draw on other trained CTF monitors at high volume times such as interim analysis or database close. The CTF monitoring team will also facilitate the training of the 2 site monitors