1. Conducting a Study Safely and Efficiently at Johns Hopkins Daniel E Ford, MD, MPH Vice Dean for Clinical Investigation July 20, 2010

2. Areas to Consider Creating and managing your research team Patient Recruitment Strategies Quality control Data management Data analysis Research participant safety Financial management

3. Research Team Principal investigator Project Director/clinic coordinator Recruiter Research Assistant/clinic staff Quality control coordinator Data Manager Programmer/analyst Statistician Administrative Assistant Financial manager Human resources manager

4. Standardized Operations SOP: Standard Operating Procedures Operations manual Data collection forms

5. Recruitment Approaching patients (HIPPA) Advertising –Needs IRB approval –Newspapers and more unique venues –Internet and social media Working with patient advocacy groups Consider complexity of trials Developing best practices

6. Quality Control Who is doing the measurements? How are study staff being trained and monitored? Is equipment being calibrated? What about data entry? –Avoid hand copying of data if possible –Duplicate data entry

7. Data Management Check for any common vocabularies and data definitions Data collection through self-report, interview or direct computer entry, scannable forms Data security –Auditing of viewing of data, entering and changing data (CFR 11 compliance) Backup of data Sharing of data

8. Biospecimens Consent Safe handling Appropriate processing and storage Transfer IT support

9. Clinical Research Management System Budgeting Sponsor Billing InvestigatorsResearch Nurse Data Manager Insurance Clearance Budgeting by Dept. Admin. Program Manager Patient/ Protocol Registry PharmacyCore Facilities Labs SoM Leadership Billing Compliance IRB Eligibility Screening EPR/Labs Integration IRB Integration Protocol Schema / Patient Calendar Billing Compliance External Recruiting Website JHED/Site Minder Integration Data Warehouse Library Research Forms Work In Progress Currently In Use Possible Future Functionality Key:

10. Research Participant Safety Develop an overall safety plan starting with identification of biggest risks Consenting process and storage of consent forms Payment of research participants Monitoring for adverse events, grading events and process for reporting –Need for Data and Safety Monitoring Board Safe distribution of research medications Management of “incidental” findings

11. Project Management Develop a reasonable time line for study activities Determine dependencies – what has to be done first? Think ahead to sharing findings through abstracts, publications and forums