Site Management, the key to the proper execution of clinical trial.
The whole process of the conduction of different clinical trials is carried out by delicacy. The entire journey before the execution and after execution is risky. The risk can be posed to the participant(s) involved in the clinical trial as well as the investigators and people involved in the trial. It is highly mandatory to take care of every process on a minute level to carry out a risk-free trial.
The proper site management by the qualified sponsors or CRO plays a vital element in assured cent percent success levels. An appropriate level of the site management empowers the clinical sites to effectively treat, retain and recruit the subjects under the security of the protocol adherence, protection of subject rights, regulatory compliance and management of the participants of the trial. The site management is not just about monitoring the clinical site; it goes beyond that. It focuses on the consistent and regular communication with the respective sites at the times of initial stages, closeouts, and maintenance. One of the most fundamental steps towards site management includes a reliable primary point of contact with the site at the time of the clinical trial. An uninterrupted regular communication must be maintained with the CRO or the sponsor. Clinical Research Associates (CRA) is considered to be the most reliable point of contact in most of the cases. A proper understanding must be maintained among all the point of contacts, to record the changes, events, issues and ask questions at the times of critical needs during the execution of trials. Every aspect of contact must be able to communicate in an easier and clear way. It may even reduce the rate of protocol violations and address adverse events, questions, and issues. The site management increases the integrity and ensures high quality of the clinical trial data. Every communication with the site manager must be appropriately filled and recorded in the Master file of the trial and the file of the investigator (regulatory binder). An exceptional record of the events must be maintained in the risk-based clinical trials which ensure the positive results across the site. A comprehensive site monitoring plans must be crafted to address the sponsor requirements and complexity of the trials. A traditional site monitoring visits must be planned to ensure the proper conduction of the clinical trials.
A proper legal site contract along with the budget should be maintained to carry out the clinical trials. The budget should contain all the expenses to conduct the clinical trials. During the initiation of the site, the site manager or CRA will oversee the training and start-up along with setting the recruitment expectations of the site. At the time of the study close-out moment, the site manager or CRA must support the respective site in the completion of the final sourced data verification of the eCRFs/CRF, assured protocol adherence, collection, and management of the safety data of the trial. At the last stage, the site management involves the finishing accountability and review of the medications and study drugs, the ultimate collection and reviews of all the relevant regulatory documents, making sure that the site is audit-ready. It is necessary that the CRA or any other additional site manager maintains the required information and monitors the site at the time of the trials. If in case a new Site Manager or CRA is appointed in the middle of the trial, then it is the responsibility of the old assigned CRA to acknowledge the new appointed CRA with the required site information. The relevant information may include the comprehensive site monitoring plans and reports, safety management plans, followed up protocol information, and subject information. The following is done to ensure consistent and clear communication among the site personnel. The site training is required to collect the high-quality error-free data, conduct the proper execution of the trial. The CRAs and the project managers for all the staff involved in the clinical trial should be trained in compliance with the local regulatory, ICH-GCP guidelines and FDA. All the activities, irrespective of the minor or major activities should be logged and recorded in adherence to the protocol. An alternative point of contact namely the site manager or the project manager must be at the site at the time of the execution of the clinical trial to make sure about the clarity of communication between the staff involved.
The best practices to follow for site management are as follows:
- Site feasibility and identification
- The proper and clear consent of all the subjects participating in the clinical trial (the subject can revoke the consent at any time without providing any particular reason)
- Obtaining the required approvals from the Institutional review boards and local ethics committees.
- Extensive plans for monitoring
- Time to time monitory visits from the initiation until close-out
- Recording and completing the number of visits per session
- Comprehensive reviewing of the site records
- Loggings and minimizing the protocol deviations and violations in compliance with the regulatory terms
- Accountability of the drugs and medications used in the clinical trial
- Document verification in context with the site monitoring plans
- Point to point site management support and monitoring
- Customized training needed for the execution of trials
- The assurance of Good Clinical Practice (GCP) including the training and motivational visits
The site plays a significant role in the proper functioning of the trials. It is mandatory to develop a robust and stable relationship with the site during all the stages of the trial. The collaboration of the site management and other aspects of the clinical trials lead to enhanced productivity and efficiency. It ensures the perfect conduction of the trial with the minimum rates of adverse events. The proper monitoring of the safety, steady communication, protocol adherence in compliance with the regulations and logging of the events and data promotes the positive close-out to the clinical trial.