|Year : 2012 | Volume
| Issue : 1 | Page : 32-34
A day in the life of a monitor!
Eisai Clinical Research Singapore Pvt. Ltd., Mumbai, India
|Date of Web Publication||25-Jan-2012|
Eisai Pharmaceuticals, 1st Floor, B Wing, Marwah Centre, Krishanlal Marwah Marg, Andheri (East), Mumbai - 400072
Source of Support: None, Conflict of Interest: None
| Abstract|| |
When at a site, the monitor will meet with the Study Coordinator, review the hospital medical records, use the internet database or paper to 'monitor' their data versus their medical records, issue queries, check master files, count tablets or vials, provide the update to the doctor, and so on. When not traveling, the monitor will work in the office, printing letters, filing documents collected from sites, writing reports and follow-up letters, responding to e-mails, calling sites, to follow-up on the pending action items, in addition to calling sites not visited recently, attending study teleconferences, attending study and company training programs, reading standard operating procedures, completing excel spreadsheets or company specific software systems, and so on. The monitor is loaded with all these different types of work requirements and most importantly each and every task is important and time bound. Different skill sets are required for different tasks and the monitor plays different roles, while doing different tasks. This article enlists the tasks that are required to be done by the monitor, the different roles played by the monitor while doing these tasks, analyze which is the most important day for a monitor, what are the tasks performed during this day, and what knowledge and skills are required for performing these tasks.
Keywords: Good clinical practice, knowledge, skills, site
|How to cite this article:|
Shah K. A day in the life of a monitor!. Perspect Clin Res 2012;3:32-4
| Introduction|| |
E6-GCP defines monitoring as, "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, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s)".  So the monitor is a person who is responsible to perform all the above-mentioned activities. The clinical research industry has given different titles to the monitor like Clinical Research Associate (CRA), Senior CRA, site manager, and Clinical Trial Assistant (CTA). The most commonly used terminology for the monitor is 'CRA'.
The job description of a monitor comprises of a big list of items that includes, providing assistance to the team in the preparation of protocols, informed consent forms, case record forms, planning documents, and so on; assist in the preparation of the required regulatory submission dossiers; assist in site evaluation and selection, or conduct the site selection visits, assist clinical sites with Institutional Review Board (IRB) / Independent Ethics Committee (IEC) submissions and ensure collection of the required essential documents for a study start-up and throughout the conduct of study; to assist in the planning of investigator meetings, preparing presentations, and so on; to conduct ongoing site training; to motivate investigators and assist in the development of any necessary aids, to allow studies to proceed expeditiously (e.g., newsletter, investigator flow charts); to maintain awareness of local regulatory requirements, and to conduct studies in accordance with SOPs, local guidelines, and ICH Good Clinical Practice guidelines; to conduct on-site clinical monitoring, which includes: Document review, ensuring accurate data recording, verifying patient data, adherence to the protocol, the GCP guidelines and SOPs; to ensure the correct storage of drugs and the diligent account of all drugs; to resolve any data queries / protocol deviations identified; to work with the Safety Officers to clarify, respond to, resolve, and track adverse event-related issues as they arise; to ensure that the data is provided to the Data Manager in a timely manner; maintain regular contact with the study sites, to ensure protocol / GCP compliance; maintain all files and documentation pertaining to the studies; to track the study progress using study tracking tools, ensuring timely and quality updates; to provide a report, as required, of each of the site visits and of the status of each of the studies and make any necessary recommendations; to maintain effective communication with other members of the clinical team and management; ensure correct archiving of files on completion of a study and so forth.
We can understand from the above-mentioned list that there are too many activities that monitors conduct and are responsible for. Obviously a monitor does not conduct all activities every day and all monitors may not be involved in all the activities. The involvement in the activities will depend on the experience of the monitor and stage of the study, that is, start-up, recruitment, follow-up or closeout. One monitor may be working on multiple studies in different phases at the same time and so will be involved in the activities of different stage at the same time.
Monitors play multiple roles while performing different tasks. Monitor is
As we understand, each of the above-mentioned roles requires different knowledge and skill sets. One of the surveys conducted within the Indian clinical research industry, to analyze the knowledge and skill sets required for a monitor gave a good overall view of the knowledge and skills required by a monitor. The survey for knowledge requirement (modules were divided in General, Ethics, Regulation, Research methodology, Data management, and states and trial execution knowledge) suggested that the general industry, ethics, and trial execution knowledge were critical for a monitor to work, followed by regulatory knowledge. In the survey for skills (divided into leadership, team work, negotiation, conflict management, interpersonal, computing, presentation and communication), for the requirement for the overall work of the monitor, all skills except leadership and computing were rated critical by almost an equal number of people. 
- A trainer while presenting at investigator meetings/site initiation or during routine discussion on requirements with the site team
- A salesperson when convincing the investigator that the study is more interesting than other similar trials for recruitment
- A planner while preparing monthly travel and other activity schedules
- A troubleshooter while helping sites for resolution of issues in different ways, depending on the situation
- A negotiator while discussing the study budget with an investigator or timeline with external vendor or internal team members
- A detective while conducting site selection or monitoring visits
- A psychologist while dealing with people at different levels, with different personalities
Looking at the data given it seems all tasks, all knowledge, and all skills are equally important. Let us go back to the monitor's job description and role plays of a monitor. If we analyze all the points carefully and review the basics of GCP and the definition of monitoring together, we can understand that it is not the training or recruitment or communication or negotiation that is the key for a monitor, but it is the review of patient data, to ensure that the right patients are enrolled in the clinical studies and all important data are correctly reported; that is the most important task of a monitor. This review of patient data does not mean only a review of source records, but also includes the review of case record forms (CRF), to ensure that correct data is reported. Although a review of informed consent forms and investigational products are given separate names, they are not really isolated, but actually a part of the review of patient-related data or what is more commonly known as source data review. The monitor cannot review the start and stop date of the drug and dose taken in the source document and CRF, in isolation of drug accountability. The dates and dose have to match with the accountability, so in turn, despite giving different names they come under the source data review.
Now we have four important questions:
Indeed we are sure about the answer of first two questions. The monitor performs the most important task of patient data review during the onsite monitoring visit and so the most important day in the life of a monitor is a day of onsite monitoring.
- When does the monitor perform this important task of patient data review?
- What is the most important day in the life of a monitor as the title suggests?
- What are the most important knowledge areas to make this day successful?
- What are the most important skills required to make this day successful?
Now to answer the third question about knowledge areas, we need to look back at the tasks performed during this day and identify the knowledge requirements for each of the tasks. The monitor needs to know the basic GCP, to ensure that the trial is conducted as per regulatory requirements. The monitor needs to know the protocol, to ensure that the trial is conducted in accordance with the same. He needs to know the investigators' brochure (IB) and the investigational product thoroughly, so as to be aware of what could happen during the study, look out for such events, and ensure that there is no underreporting of events. SOPs are made to ensure that the conduct is as per regulatory requirements and so forth, but in the absence of SOPs, a monitor can still perform the key task thoroughly if he has the knowledge of all the required guidelines and regulations. This does not mean that SOPs are not important, but the point is that at times companies place emphasis on the training, on SOPs and assessments, so much so the key factors are missed out, or not given sufficient emphasis. Organizations need to place more emphasis on the ongoing training and assessment of the monitor regarding the knowledge of GCP, Protocol, and IB, as they do for SOPs.
The fourth question is the toughest because it talks about skill sets. The monitor performs a lot of tasks during the day of onsite monitoring visits. Although we may say that to perform monitoring successfully the most important skill is an eye for detail or that of a detective, but it may not really be sufficient to successfully complete the task. To review all documents within the required timeframe, planning is required. To raise the point of query about the data and convince the doctor, good communication and negotiation skills are required. To ensure that the issues are conveyed in an accurate, simple, and understandable manner so as to avoid them from happening or repeating; the monitor needs to be a good presenter / trainer. All these skills are related to the review or the most important task of ensuring that the right patients are enrolled in the study and correct data is reported. Thus there are more of soft skills required than knowledge, for a monitor to complete the task effectively and successfully. Therefore, organizations also need to give importance to soft skills training for monitors, rather than concentrating only on the knowledge areas.
After all this discussion, it may seem that the monitor's job could become mundane after a few months; however, for a monitor every study, every site, and every visit is a new experience. Every site is different, even within the same study. Some sites will ask for suggestions and hand holding for every small thing, however, some may be conducting trials before the birth of a monitor and are not ready to listen at all. Some sites will do well due to their diligence and dedication to work, however, some will repeatedly make mistakes and have deviations, despite the training and follow-ups, due to their negligence or busy schedule. Monitors come across new issues during each monitoring visit and need to be very good trouble shooters to find different ways to resolve each of them. Therefore, there may be one important day in the life of a monitor, but there is no typical day in the life of a monitor.
| Disclaimer|| |
All opinions expressed herewith are those of the author and not of any of the organization.
| References|| |
|1.||Food and Drug administration ICH E6 Good Clinical Practice consolidated guidance. Rockville, MD: FDA; 1996. |
|2.||Ajay S, Bhatt A. Training needs of clinical research associates. Perspect Clin Res 2010 ;1:134-8. |