1 / 6

Initiation Visit

Initiation Visit. Initiation Visit. An Initiation visit should never take place before unconditional written approval of the IRB/IEC has been obtained Training / Explaining Initiation visit = GREEN LIGHT for the recruitment of patients in the trial. Initiation Visit.

efrank
Download Presentation

Initiation Visit

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. Initiation Visit

  2. Initiation Visit An Initiation visit should never take place before unconditional written approval of the IRB/IEC has been obtained Training / Explaining Initiation visit = GREEN LIGHTfor the recruitment of patients in the trial

  3. Initiation Visit • Once Ethical Approval has • Been Obtained: • Arrange all necessary materials for the site: • - Medication • - Case report forms • - Protocols to sign • - Financial agreements • - Investigator file • Make an appointment for an Initiation Visit • Ensure that these materials arrive at the site either before or during the initiation visit • Before the Initiation Visit We Need: • Essential documents • IRB / IEC approval • Composition of IRB / IEC • Site specific patient information sheet • Curriculum Vitae • Lab reference values and certificate

  4. Initiation Visit • Investigator’s File : File on site that contains all relevant documents of a trial, essential documents, patient ID list, study staff members signature list, drug receipts forms, correspondence • During the initiation visit, everything concerning the study -ICH GCP, Protocol, the CRF, Investigator file etc should be explained to / discussed with the investigator and staff • Visit all participating departments (pharmacy, lab, wards). Explain all that is relevant to these departments • Signing of protocols and financial agreements

  5. Initiation Visit • A major problem is to get enough time from the investigator and staff to go through everything • Another problem is making appointments with all people involved on the same day • Be well prepared, organised and know what you want to achieve • Priorities: what has to be signed/ explained

  6. Initiation Visit : Follow Up Activities • Visit Report • Follow up letter • Regular telephone contact to encourage recruitment • Plan first monitoring visit (if possible)

More Related