Project Management Workshop Carmen B. Jacobs, RN,OCN, CCRP Office of Multicenter Clinical Research

Outline Enrollment Source Data Collection Data Management Standard Operating Procedures (SOPs) Quality Assurance Follow-up

Enrollment  General Considerations:  Know the patient population  Support system  Family, friends  Barriers  Socio-Economic  Language  Knowledge deficit  Culture  Transportation  Resources

Enrollment  General Considerations:  Know yourself  Barriers  Language  Knowledge deficit  Culture  Pre-conceived ideas regarding the protocol (e.g. phase 1 studies versus phase 3)

Enrollment  General Considerations:  Know the disease  Know the protocol  Eligibility criteria  Know community resources, outreach groups  Multidisciplinary team

Source Data Collection All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification. -ICH Topic E6(R) Guidelines for Good Clinical Practice Section 2.10

Essential Documents – Documents that individually and collectively permit the evaluation of the conduct of a trial and the quality of data produced. Source Documents – Original records that substantiate the existence of clinical trial subjects

Data Management  General Considerations:

Standard Operating Procedures (SOPs)  General Considerations:

Follow-Up  General Considerations:

wisdom after “There is no wisdom equal to that which comes after the event.” - Geraldine Jewsbury