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Conducting a Study Safely and Efficiently at Johns Hopkins

Conducting a Study Safely and Efficiently at Johns Hopkins. Daniel E Ford, MD, MPH Vice Dean for Clinical Investigation July 20, 2010. Areas to Consider. Creating and managing your research team Patient Recruitment Strategies Quality control Data management Data analysis

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Conducting a Study Safely and Efficiently at Johns Hopkins

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

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