Training Investigators & Site Staff
Key Services at WEP Include the Following:
Investigator and Site Staff Training on Study Protocol
We provide comprehensive protocol training to ensure that investigators and site staff fully understand:
- Study objectives, endpoints, and inclusion/exclusion criteria.
- Treatment regimens and dosing schedules.
- Patient recruitment and retention strategies.
This training helps minimize protocol deviations and ensures consistent execution across multiple sites.
Good Clinical Practice (GCP) and Regulatory Compliance Training
We ensure that all investigators and site personnel receive GCP training, ensuring compliance with ICH-GCP, FDA, EMA, and local regulatory guidelines. This training covers ethical considerations, informed consent processes, and data integrity standards. If required we will provide certification programs to verify that staff are adequately trained before trial initiation.
Electronic Data Capture (EDC) and Clinical Systems Training
We train site staff on the use of Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle InForm, Veeva Vault). Staff receive hands-on training in data entry, query resolution, and adverse event reporting. Training also includes other trial technologies such as Interactive Response Technology (IRT) for patient randomization and drug supply management.
Adverse Event (AE) and Serious Adverse Event (SAE) Reporting
Investigators are trained on how to identify, document, and report AEs, SAEs, and Suspected Unexpected Serious Adverse Reactions (SUSARs). We ensure sites understand regulatory reporting timelines and documentation requirements. Training reduces underreporting or misclassification of safety events, ensuring accurate pharmacovigilance.
Risk-Based Monitoring and Quality Assurance
We educate site personnel on Risk-Based Monitoring (RBM) principles, ensuring proactive identification and resolution of risks. Training includes corrective and preventive actions (CAPA) to address protocol deviations, data discrepancies, and non-compliance issues. Sites are trained on maintaining proper documentation for audits and inspections.
Investigator Meetings and Site Initiation Visits (SIVs)
We will organize Investigator Meetings (IMs) and Site Initiation Visits (SIVs) to provide hands-on training before the trial begins. These sessions include:
- Protocol review and Q&A sessions with medical monitors.
- Practical demonstrations on study procedures.
- Case studies and scenario-based learning to reinforce compliance and patient safety.
Ongoing Training and Refresher Courses
Ongoing support ensures that staff remain updated throughout the study. Our team provides continuous training sessions, especially when:
- Protocol amendments occur.
- New regulations are introduced.
- Site performance issues are identified.