This unique self-study curriculum is designed to provide a hands-on perspective surrounding the day-to-day work of the clinical research monitor. Newly updated to include requirements of ICH GCP E6 R2, this 7-volume set provides the fundamentals of being a Clinical Research Associate (CRA) in today’s environment. Each volume can be used as a stand-alone reference or as a complete self-study training series.
The following content is included (by volume):
- Volume 1: An Overview of Drug Development is written to introduce new CRAs to the drug development process, while contextualizing it to the role of the CRA. Included are important terms and acronyms encountered by CRAs, as well as what happens before and after a clinical study.
- Volume 2: Identifying and Screening Investigators focuses on the characteristics of good clinical investigators and the process of finding investigators who meet the needs of the protocol, the formal plan for the study. Included are procedures for investigator identification and screening, first contact and investigator selection.
- Volume 3: Conducting Prestudy Visits describes the process of preparing for the site visit, conducting the visit, and assessing the site. Included are details regarding meeting agendas and scheduling, budget negotiation techniques, site assessment criteria and necessary discussion points, and recommended procedures and documentation.
- Volume 4: Conducting Study Initiation Visits covers the training of site staff to conduct the study. Included are guidelines for planning, conducting and documenting a study initiation visit, including the objectives, preparation, task analysis and documentation and follow-up.
- Volume 5: Conducting Routine Monitoring Visits describes how to prepare for, conduct, and follow up monitoring visits from the time that the first subject is enrolled to the final site visit. Included are strategies for ensuring that the study is being conducted according to the protocol and good clinical practice (GCP).
- Volume 6: The CRA's Reference for Adverse Events serves as a reference for the AE-reporting process and provides procedures for the monitor to follow.
- Volume 7: Test Your CRA Knowledge is filled with exercises which test your knowledge and understanding of the material presented in the previous volumes. Answers for each of the questions are included in the second section of the manual, making immediate feedback available.