Clinical Trial Agreement (CTA) Process for CRA/CRO at Siriraj Institute of Clinical Research
Explore the streamlined Clinical Trial Agreement (CTA) process for Clinical Research Associates (CRA) and Contract Research Organizations (CRO) at the renowned Siriraj Institute of Clinical Research in Thailand. From document review to signatory process, follow the detailed steps for successful collaboration on clinical trials.
Uploaded on | 0 Views
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author. If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
You are allowed to download the files provided on this website for personal or commercial use, subject to the condition that they are used lawfully. All files are the property of their respective owners.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author.
E N D
Presentation Transcript
CLINICAL TRIAL AGREEMENT (CTA) PROCESS FOR CRA/CRO
ATTENTION 1. CTA : Mrs. Chalermkwan Vamvanij E-mail: chalermkwan3410016@gmail.com Tel: +662-4192960 Siriraj Institute of Clinical Research (SiCRES) Faculty of Medicine Siriraj Hospital, Mahidol University 10thFloor SIMR Building ( 10)
REVIEW ATTACHED DOCUMENTS 1. 1stCTA Drafted CTA CTA Checklist Currently protocol A copy of COA Cover letter from PI s department for draft consideration* 2. Amendment CTA Drafted CTA Amendment CTA Checklist Currently protocol A copy of COA Cover letter from PI s department for draft consideration* A copy of previous CTA *Attention:
REVIEW ATTACHED DOCUMENTS 1. Institution name: Mahidol University by Faculty of Medicine Siriraj Hospital Address: 2 Wang Lang Road, Bangkoknoi, Bangkok 10700, Thailand Bank Account Banking Name: The Siam Commercial Bank Public Company Limited. Branch: Salaya Branch SWIFT Code: SICOTHBK Account Name: Mahidol University Account Number: 316-403836-7 Bank Address : 28 Phutthamonthon 4 Rd., Salaya, Phutthamonthon, Nakhon Pathom 73170 THAILAND Details of payment are indicated as follows: Protocol No. PI name Invoice No. (if indicated) Dean, Faculty of Medicine Siriraj Hospital Prof.Prasit Watanapa, M.D., Ph.D. 2. 3. 4.
TIMELINE FOR CTA REVIEWED Total budget equal or more than 25M Baht Total budget less than 25M Baht Document package was sent to SICRES (via PI s department) Document package was sent to SICRES (via PI s department) SICRES register SICRES register 30-35 days 5-7 Days SICRES contact CRA/CRO (E-mail/Tel) SICRES contact CRA/CRO (E-mail/Tel)
CTA SIGNATORY PROCESS CRA/CRO sent final draft via email: chalermkwan3410016@gmail.com 30 min Document package for signatory CTA 1. CTA 3 copies 2. COA (PI+ Project) 1 copy 3. Cover letter from PI s department for signatory CTA SiCRES verify document package Dean signatory process 5 days
