Issue categories

Late AE entry was found for patient 001 i.e. myalgia onset date 28Feb2023.

• Delayed Data Entry ≥ 15 Days

• Document

• Delayed Data Entry ≥ 30 Days

• Other

The approval letter of site close out notification is not obtained from the EC yet.

• Monitor note

• Other

• Regulatory

• Document

IP has been changed Manufacturing packaging process. It has been affected on LPI for shipment to all sites in Thailand.

• Drug

• Shipping/Courier

• Regulatory

• Pharmacy

Subject re-consented Main ICF v.4 dated 11-Dec-2022 on 6-Feb-2023 but ICF process was not recorded in EMR.

• Document

• Procedure

• Informed Consent

• Other

RBR consent was not signed by subject but RBR sample was collected.

• Informed Consent

• Sample

• Other

• Procedure

 

Since the protocol and ICF were approved from EC since 4 Jan 2023. The approval document was received on 24 Jan 2023. This re-consenting process should be done at the soonest visit on 30 Jan 2023, but it was conducted and signed on 20 Feb 2023.

 

However, the additional safety information was informed to the patient since 9 Jan 2023.

• Procedure

• Recruitment

• Monitor note

• Informed Consent

Site has been activated on 3 Dec 2022 but no screening as of 26 Feb 2023

• Resource

• Recruitment

• Investigator Comment

• General

Data logger calibration certification expired since 23 Jul 2022.

• Document

• Equipment

• Pharmacy

• Drug

Study coordinator and Pharmacist have not been assigned for this study. However, they performed study specific tasks.

• Document

• Deviation

• General

• Resource

Tissue sample collection lab kit are not sufficient at site. Site have new screening subject and required to send tissue sample on 23-May-2022.

• Sample

• Supply

• PK Sample Collection & Storage

• Procedure