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UK JSLE Cohort Study

UK JSLE Cohort Study. Study Overview and Good Clinical Practice for Local Centres Dr Michael Beresford Chief Investigator. Logo. Website: Overview and GCP. Collaborating Centres. UK JSLE Study Group. UK JSLE Cohort Study. UK JSLE Cohort Study & Repository. Good Clinical Practice.

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UK JSLE Cohort Study

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  1. UK JSLE Cohort Study Study Overview and Good Clinical Practice for Local Centres Dr Michael Beresford Chief Investigator Dr MW Beresford

  2. Logo

  3. Website: Overview and GCP

  4. Collaborating Centres

  5. UK JSLE Study Group

  6. UK JSLE Cohort Study

  7. UK JSLE Cohort Study & Repository Good Clinical Practice Dr MW Beresford

  8. Study Manual • Overview of all SOPs • What and how to do it • Available: • Website • Hard Copy – Master File • Hyperlink version

  9. Good Clinical Practice • Study Manual • Joining Registry • Standard operating procedures • Patient logs • Information sheets / consent forms • Application to use data / samples • Authorship / Publication policy • Data protection

  10. GCP (ICH 1996): Aim • To prevent poor research methods and biased results from effecting clinical practice. • Primarily designed for clinical trials, the guidelines are also very relevant to observational studies, such as the UK JSLE Cohort Study & Repository

  11. Role of Local investigator • ICH GCP Section 4: should be a consultant experienced in research studies, and should: • Ensure adherence to protocol in their centre • Responsible for health and welfare of patients during participation in study • Instruct and train staff on study protocol • Delegate study tasks to appropriately qualified staff • Maintain essential documentation for the study

  12. Joining the Study • Flow diagram of whole process • What needs to be done when

  13. Applying for LREC / R&D • Carla Roberts • Complete all paper work possible • Can be in direct touch with local R&D etc.. • Progress & Problems? • Please ask Carla and inform

  14. Master File • ESSENTIAL • Helpful check list of what is needed • 2 pages • Carla send most main things to be slotted in

  15. To be kept in Master File and copies sent to Study Administrator (Carla): Letter of Agreement CV PI and all taking part (on LREC) Study Personnel Signatures Everyone involved in data collection Certificates of GCP Initial & Updates (annual?!) Notification of LREC / R&D Documentation Essential Documentation

  16. Informed Consent • ICH GCP (2.9): "Freely given informed consent should be obtained from every subject prior to study participation“ Giving information: • Initial contact by letter, clinic or on the wards: • Provide information about the study to take away & allow a reasonable length of time (3 days where possible) to read & discuss Further discussion: • Ask patient to take part in study • Sign a consent form and give patient copy to keep ALL staff taking consent – fully trained

  17. Recruitment Logs • Participant Screening Log • Participant Recruitment Log • Participant Identification Code List • Recruitment Folder • Part of Master File (6 & 10) • Logs • Investigator’s Copy of Consent / Assent

  18. Participant Screening Log • Note down ALL patients screened for eligibility • Avoids approaching twice • Denominator data for cohort

  19. Participant Recruitment Log • All patients recruited • Tracks patients and what happens to them

  20. Participant Identification Code List • ESSENTIAL • Separate from data forms • Links Study Number to personal details

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