1. January 19, 2013 Chair: Mr. Bob O’Neill Making Studies Work —a discussion of challenges and solutions to the management of studies

2. 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

3. 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)

4. 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

5. 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)