University:
Coventry University
Course:
B940 | Biomedical Science
Academic year:

2023
Views:

170

Pages:

3
Author:

Badusha S.

Clinical twal protocol What is protocol. Amendment. → elements how corchild Protocol. Inlenty y Dr. cayety The document conducted describes how a CT will be Cobjectives, design, methodology, Statistical consideration, onganian ga ensure safety 9 trial subject, & integrity I data Colle Case Record Form Printed, optical, or electrome document designed to record all g the protocol. → Regumed information to be repertus to the Sponsor for each subject / pontinput im et. → Record g cimical study observation & othn injomations for each Subject ou por praloch. Objective & rationale. Is a Jor a sect det cinlig the seventyci rationale protocol & justiyn in meclical & sürenliye literature for hypotheis being pro pond Protocol Amendments. Any change to rotocol doc / IC that syfect suintyce intent, stoly denègy, pt safety or comidered humom subject protect is amendment. om Must be approved by EC & RA Minor chonger For add "I sajety og patuppe -lotyy to licening / regalatony authority Major changer Introducing a new chung farm Approval jron Éc & licencing / reg. anthity - Content 1. Title page Title y C.Study Protracoll study no, vernon è data IND name no gimusigital chuy Complete nerve & addum y Spomer/CRO. List ginnastigatos -Inst afjikelios Site location Nomme 9 other lopt & clinical lebs 2. Study rationale - greson for penjaning the study in this popul. 3 Stady objective - 4-Study dervign rationale & design, methwols & procedure of stoly - Show cheul- 5. Study populh 6. Subject eligibility - Inclusion / exulticon. 7. Study amemment - Man, procednen, mothers 8. Study conduct 9. Study + reatint 10-AE u. Ethical consideration 12. Study Monto my & supenusion 13. Investig atul Product Mgmt 14. Data Analysi