The monitoring of clinical trial is generally performed by an experienced person called monitor or Clinical Research Associate (CRA). The qualification of a monitor could be Bachelor’s or Master’s degree in Life or Medical sciences. The person has to be a self-starter with good interpersonal relationship skills, a detail-oriented good writer and as well a good speaker. A monitor has to be self-confident and should know how the sponsor/CRO wants the study to be done, has to be flexible and adaptable to changing environment, has to be focused, manage time well and follow through ongoing problems and commitments.
Qualities of a CRA/ Monitor : A clinical research associate (CRA) or Monitor is generally appointed by the sponsor or CRO. A monitor has to be trained appropriately and should have scientific and/or clinical knowledge to monitor a trial properly. The qualification of a monitor should be documented by sponsor. The monitor has to be thoroughly familiar with study related products and documents like Investigational product /drug, clinical study protocol, case report form, informed consent form and others. A monitor should also have in depth knowledge of different ethical guidelines like ICH GCP, CDSCO-GCP, Declaration of Helsinki as well as ICMR Guidelines for ethical conduct (for clinical trials in India). A monitor should also be very thorough about the standard operating procedures and regulations specific to different regulatory authorities like Schedule Y of Drug and Cosmetics Act (India),21 CFR Part 50, 54, 56 and 312 (US FDA) etc. Apart from these responsibilities Source Data Verification (SDV) i.e. verification of data recorded in CRFs with the source documents is a major duty of the monitor. Source documents are the original documents and/or records in which raw data are collected during a clinical trial. Some of the examples of source data are hospital records, clinical site and office charts, progress notes, laboratory reports, ECG strips, X-rays, CT/PET scan, subject diaries, questionnaire responses, pharmacy dispensing records, microfilm, photographic negatives, recorded data from automated instruments.
Responsibilities of a Monitor: A clinical trial Monitor plays a vital role to ensure that the overall trial is going on well. The main responsibilities of a monitor are:-
- Act in accordance with sponsor’s (or CRO) requirements.
- Main line of communication between Sponsor/CRO and Site.
- Verify the Investigator’s qualifications, resources (staff, equipment, lab).
- Verify Investigator’s compliance with protocol.
- Report findings, processes and conduct of the study.
- Negotiate the twists and turns that can come up during the course of a trial.
- Function as eyes and the ears of the study and that require the ability to make observations considering multiple points.
Before a visit, the monitor should contact the site 2-4 weeks prior to the tentative site visit to schedule the visit, issue confirmation letter or e-mail, check previous visit follow-up letter. During a visit the monitor will assess the study, staff, infrastructure, check regulatory files and study records, discuss/ assess any problems and issues identified, conduct a briefing meeting at end of visit. The monitor has to complete a monitoring/assessment visit report and submit the report to the sponsor, distribute the monitoring report/follow-up letter to the site and the site should file the monitoring report and/or follow-up letter in their regulatory file. Monitor also has to review corrective action, outlined in the follow-up letter, during the next visit. Adequacy & availability of all site facilities for the conduct of the study staff, pharmacy, laboratory, clinical unit, storage area, monitoring, site initiation visit has to be checked properly. To uniformly provide study-specific information to Investigator(s) and other study team prior to study start up monitor will be checking in the site regulatory documents, investigational product, Case Report Forms (CRFs), site master file, if lab supplies are sufficient, equipments are working well and if the drug has been stored properly.
For the Interim monitoring visit, the monitor has to record the visit in the monitoring log, has to check if the Investigator has adequate qualifications and resources that remain same throughout the trial. Written informed consent was obtained before each subject’s participation, and only eligible patients are being enrolled. A monitor’s duty is to ensure that the Investigator and team are performing their tasks as per the approved protocol, written agreement with the sponsor/ institution.
Talking to Investigator and the team: The Monitor should communicate to the site investigator about any observed deviations from the study protocol and also should train/ suggest them how to conduct the trial in compliance with the protocol. He should make sure that whatever mistakes was found in his last visit should not be repeated for the next time.
He should also reinforce that the site team should collect wall adverse events (AEs) appropriately and report them within the time periods required by GCP, the protocol, the IRB/IEC, the sponsor, and the applicable regulatory requirement(s).
Source Data Verification: One of the major responsibilities of a monitor is verification of source data. During this process the monitor checks the accuracy and completeness of CRF entries, source documents and other trial-related records against each other, if the data in CRFs are consistent with data in source documents, dose/therapy modifications are well documented, concomitant medications/ illnesses are reported, visits that the subjects fail to make, tests that are not conducted, and examinations that are not performed are clearly reported as such on the CRFs,all withdrawals and dropouts of enrolled subjects from the trial are reported and explained on the CRFs,and check if all data data queries have been resolved.
Investigational Product: Regarding the investigational product the monitor should check if the storage times, temperature and conditions are acceptable, sufficient supplies are available throughout the trial, drugs/treatments are properly supplied to subjects who are eligible to receive it and at protocol specified dose. Monitor should also ensure that subjects are given instructions by the investigator on correct use, handling, storage, of the investigational product.
Monitoring Report: A Monitor has to submit a written report to the sponsor after each trial-site visit or any related communication. The trial report should include the date, site, monitor’s name, investigator’s name/others contacted. The report should also include a summary of what the Monitor has reviewed and the Monitor’s statements concerning the significant findings/facts, deviations and deficiencies, conclusions, actions taken or recommended to be taken to secure compliance with the study protocol. Thus, a CRA/monitor is a key person who is employed by the study sponsor/CRO to ensure that a clinical trial is conducted in compliance with the study protocol at each trial site.
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