Study Management
1. Clinical Monitoring Plan
A clinical Monitoring Plan is a document that describes the monitoring responsibilities of all the parties involved, the tools to be used and the processes to be followed throughout the study to ensure validity, accuracy and integrity of the data. It is highly dependent on the study and the budget and as such a final Protocol is mandatory in order to guide its development. In the monitoring plan one shall include the frequency of on-site and remote monitoring visits as applicable that the CRA will perform in every phase of the trial, the variables that must be source data verified (SDV) by the CRA on site and a description of all remote monitoring activities. The monitoring plan is an essential document for the study manager in order to plan accordingly the oversight of the CRAs and ensure the appropriate allocation of FTEs throughout the whole study period.
Key elements of a Clinical Monitoring Plan:
- Site Training on study specific procedures
- Monitoring – Source Data Verification & Frequency of visits
- Visit Reports & Follow up letters
- Remote Monitoring – Telephone Contacts
- Close-out process & Data retention
- Site Files maintenance and methods & frequency for Quality Checks
- Safety Monitoring: Safety Events Reporting
- Communication plan, escalation of issues & Protocol
Deviations handling - Randomization & Unblinding process
- Investigational Medicinal Product Accountability & Compliance
- Laboratory samples processes and storage
2. Project Management Plan
You can never stress enough the importance of a Project Plan for a clinical trial. Without one, there is absolutely no control of the study. A project plan may be implemented in various tools ranging from a simple excel spreadsheet and study manual to advanced project management software. The use of a Project Management software is highly recommended as clinical trials tend to be high on the complexity scale and require dynamic and easy to use environments for project oversight.
The Project Manager of the study shall consult the Project plan daily, to ensure delivery of key activities, vendor oversight and milestone progress. A project plan should not be too detailed as it becomes hard to follow and it shall have a clear outline of the critical path for the project.
Key elements of a Project Management Plan:
- Study Team, roles & responsibilities
- Study activities: Planning, ownership & timelines:
- Start Up Activities
- Clinical Operations activities
- Data Management activities
- Pharmacovigilance activities
- Study Team training
- Quality Assurance & Risk Management activities: Issue management & escalation, review of Monitoring Visit Reports, frequency of Monitoring Visits vs Clinical Monitoring Plan Quality Check of Study Files
- Communication flow
- Overview of study Budget
3. Study Compliance Metrics
Apart from the high-level project plan, of course detailed metrics are key in helping the study team to identify trends, address actions proactively and ensure complete oversight of the study. Here is where a close collaboration with the biometrics team of the study is essential. It is highly recommended that a specification document is produced before the study start where all metrics that are required to be produced and their frequency should be outlined. Example of key metrics could be site performance indications are:
At study level:
- Start-up metrics: planned vs actual submission dates
- Data entry & Query resolution timelines
- Protocol deviation process
- Trial Master File completeness
- Safety reporting compliance
At CRA level:
- Finalization of Visit Reports & follow up letter submission within timelines
- Frequency of monitoring visits vs Agreed frequency based on Monitoring Plan
- Timely follow up of issues & closureSuch metrics will be the only way to ensure that the management team can have true oversight of the project at any given time point and to plan ahead to ensure successful delivery of crucial milestones such as a Data Base Lock.
4. Communication Plan
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