January 19, 2013

Chair: Mr. Bob O’Neill

Making Studies Work —a discussion of challenges and solutions to the management of studies

• Feasibility: (i.e., adequate resources, adequate expertise, ability to recruit the required number of participants and obtain the required information from them)

• Ethics : (i.e., processes in place to ensure that laws, norms, participant rights, sensitivities, etc. are all followed);

• Accountability: (i.e., having detailed records of all study-related activities, decisions, etc.);

Some principles of a well-managed study

•Accuracy: (i.e., accurate measures, data quality procedures, etc.);

• Timeliness: (i.e., getting the study up-and-running, fully implemented and completed on schedule);

• Etc.

Some principles of a well-managed study (continued)

•Management of personnel: (i.e., clear roles, a communications mechanism that is inclusive & efficient);

•Paperwork: (i.e., contracts, ethics review forms & regulatory forms, administrative documents, information forms, tables, log sheets, questionnaires, etc.)

•Recruitment procedures: (i.e., a carefully thought-out and structured plan for participant recruitment);

Some elements of study management

•Data management procedures: (i.e., for collecting, managing, monitoring & validating the data);

•Laboratory procedures: (i.e., effective mechanisms for the collecting, shipping and processing specimens);

•Site management procedures: (i.e., effective site training, study operating manuals and other resources to ensure that each site is fully prepared to implement the study);

•Study Manager: (i.e., a trained administrator to take charge of the study (thus freeing up the investigators to focus on the scientific aspects).

Some elements of study management (continued)