Clinical Site Monitoring for Research in Africa

A clinical research associate (CRA) is also called a clinical research monitor. Clinical research associates are trial monitors with a degree in a biological science. They monitor the trial to ensure data quality & integrity, ensure subject safety, and ensure the trial is being conducted in accordance with the protocol, regulatory requirements and ICH GCP guidelines.

A risk-based approach to monitoring in clinical research refers to the process of quality assurance through monitoring and mitigating risks. Quality controls in risk-based monitoring are there to identify any risks that could affect the study, assessing, and mitigating them throughout the duration of the study.

According to the ICH GCP guideline glossary definition, an audit is “A systematic, independent examination of a trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), good clinical practices (GCPs) and applicable regulatory requirements.”

Monitoring, on the other hand, is performed in-house to verify source data congruence with the CRF, ensure protocol compliance and verify subject safety.

A Clinical Research Associate is responsible for going to the site to ensure that the trial is being conducted in accordance with the protocol and according to ICH GCP guidelines. A Clinical Research Coordinator (CRC), on the other hand, is located at the sponsor’s or CRO’s sites and coordinates the production, filing of essential documents in the Trial Master File.

A contract clinical research organization (CRO) is a company that provides clinical research services to the medical device, pharmaceutical, and biotechnology industries. A clinical research associate (CRA) is a role within a CRO or pharmaceutical company that specializes in trial monitoring.

A monitoring plan is put in place to ensure the clinical research monitoring process is quality controlled and produces accurate results. The following details must be included in a monitoring plan:

• A monitoring strategy and its rationale
• A responsibility matrix (a breakdown of who is responsible for each monitoring activity)
• Monitoring procedures, including site initiation and scheduling for on-site monitoring visits, for-cause visits, and close-out visits
• The duration & frequency of visits and what activities must be performed at each visit

Clinical site selection is a crucial step in the outcome of any clinical research. Luckily, Infiuss Health is here to find the most suitable site for your study.

We have a network of multi–speciality sites and investigators, which have been pre-evaluated for their qualifications, experience, resources and capabilities. We identify sites in our network across Africa that are a good fit for your clinical research and arrange site selection and initiation visits, to select and train the sites.

Additionally, we source experienced principal investigators for your study, and manage every aspect of the trial.

Clinical research can be subdivided into 4 phases.

1. Phase 1 trials are first-in-human studies that involve testing an investigational product in healthy volunteers to determine the tolerability, pharmacodynamics and pharmacokinetics of a drug. They provide information on the tolerable range of doses, and preliminary dose-response findings. The results are analyzed and submitted to the Food and Drug Administration (FDA). A successful outcome engenders enough confidence to proceed with the next phase: Phase 2 studies. Once the results have been evaluated by the FDA and deemed in accordance with FDA guidance, the trial moves to the second phase.
2. Phase 2 trials are performed in a few patients with the disease to be treated and focus on the effectiveness and dosage of the treatment. Testing is conducted in a few (12-50) patients with the specific indication to assess the effect of different doses on the biomarkers of the disease. The optimum dose, that facilitates the maximum efficacy with the least side effects is also sought.
3. Phase 3 utilizes the dose, safety and efficacy information obtained from phase 2, to observe the effects of the investigational product on a larger and more diverse group of patients with the indication of choice that is representative of the population that will receive the drug post launch.. Pending results of Phase 3 testing, the treatment is submitted for FDA approval.
4. Approval and monitoring: once the FDA approves the treatment, a post-approval monitoring process starts. This process is referred to as post-market surveillance or adverse event reporting. The focus is on flagging any adverse events that occur from the treatment’s usage in real-world settings

While Africa has promising sites for Covid-19 vaccine testing, there are surprisingly few Covid-19 studies being run in Africa. If you’d like to conduct Covid-19 trials in Africa, Infiuss Health is here to be your guide to clinical research and help you find the best facilities and participants for your research.

Investigator site files (ISFs) are files held by the site that contain all essential documents pertaining to the conduct of the clinical research. The documents show that the clinical research site and personnel are following standard operating rules and procedures for handling the investigational product, collecting data, maintaining audit trails and ensuring participant safety in accordance with ICH GCP guidelines.

A trial master file contains essential documents which individually and collectively permit the evaluation of the conduct of the clinical research.

Trial master files can be divided into Investigator Trial Master File and Sponsor Trial Master File. In trials sponsored by a company, trial master files (TMFs) are held by the sponsor and contain trial documents (approvals,, protocols, investigational brochures, instructions, guidelines) and documents related to the investigational product (shipment and storage records, certificates of analysis). Investigator TMFs contain almost identical documents, but are held at site.