1 / 4

MODULE E: Investigator Qualification

MODULE E: Investigator Qualification. Denise K. Thwing, MAS, RN, CCRA April 14, 2010. Clinical Monitoring Plan Outline. Scope of Work TORO Clinical Timelines Contact List Communication plan – internal/sponsor/sites/third parties Site assignments/CRAs Training Protocol highlights

andra
Download Presentation

MODULE E: Investigator Qualification

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. MODULE E:Investigator Qualification Denise K. Thwing, MAS, RN, CCRA April 14, 2010 Version: Final 14-Apr-2010

  2. Clinical Monitoring Plan Outline • Scope of Work • TORO • Clinical Timelines • Contact List • Communication plan – internal/sponsor/sites/third parties • Site assignments/CRAs • Training • Protocol highlights • Translation documents Version: Final 14-Apr-2010

  3. Clinical Monitoring Plan Outline • Trial Master file • Study forms • Start up procedures • Site selection process/procedures • Site initiation process/procedures • Status reports • IMV process/procedures • AE reporting process • SDV Version: Final 14-Apr-2010

  4. Clinical Monitoring Plan Outline • CRF transmittal/Imaging/EDC • Queries/sDCFs • IP • Laboratory • Close-out Process/procedures • Archiving • Subject Transfers Version: Final 14-Apr-2010

More Related