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Running clinical trials and DM in Africa, using Open Clinica

Running clinical trials and DM in Africa, using Open Clinica. Tina Dannemann Purnat tina.purnat@gmail.com Boston, June 2013. Context Challenges & Strategies. Work context. Funding schemes Infrastructure, access, communication Staffing Clinical research capacity

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Running clinical trials and DM in Africa, using Open Clinica

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  1. Running clinical trials and DM in Africa, using Open Clinica Tina Dannemann Purnat tina.purnat@gmail.com Boston, June 2013

  2. Context Challenges & Strategies

  3. Work context • Funding schemes • Infrastructure, access, communication • Staffing • Clinical research capacity • CDM budgeting and capacity

  4. Challenges & Strategies • Politics of partnership and workplace • Preconceptions & culture • Knowledge & capacity

  5. Using OC to teach CDM • Stepwise adoption of OC at site • First, emphasize OC as a CDMS without EDC • Focus on streamlining the implementation of paper CRFs • Train and teach shift in CDM’s responsibility, away from data entry, into DM • Empower and motivate staff

  6. My wish list • A community supportive of “absolute beginners” • multilingual studies • E-diary, patient scheduling system • Expansion of web service functionality • Live reports on status of DNs and study, per site • Satisfy paper-to-OC (DDN) and EDC equally

  7. Thank you! tina.purnat@gmail.com

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