Quiz TIPS Part 2/2023

What is the primary objective of decentralized clinical trials?

• Reducing patient involvement

• Increasing patient convenience

• Decreasing data accuracy

• Expediting regulatory approvals

What is "patient-centricity" in decentralized clinical trials?

• Focusing on the needs and preferences of patients

• Focusing solely on the needs of the research team

• Ignoring patient feedback

• Reducing patient involvement

What are some potential barriers to the adoption of decentralized clinical trials?

• Increased patient convenience

• Data security and integrity concerns

• Reduced regulatory oversight

• Faster study completion

What is direct to patient (DtP) in clinical trial ?

• A demand care and enables patient to obtain medical treatment on their own technology and at a time convenience for them

• Making scheduled shipments of medication from Hospital or central pharmacy to local pharmacy where the medication may be picked up by patient

• Intervention that are carried out by having personal contact with patients out of site or done remotely

• A patient centric approach in which supplies are prepared, packaged, labelled and then shipped to the patient's or caregiver's home

What is the most important measurement before courier handing the IP to the patient?

• Ensure to obtain informed consent form of direct to patient (DtP) and/or subject agrees to the handover of name and address to the courier if ICF is not available

• Ensure to comply with the Sponsor’s method of transportation

• Ensure the transportation temperature is within the approve limit

• Ensure the procedure is agreed by the PI and approved by the sponsor.

Who is the responsible person to acknowledge/authorized the Home Health Care (HHC) visit?

• Study Coordinator

• Nurse

• Principal Investigator

• CRA

Patients are not required to give consent for the Home Health Care visit

• True

• False

The Malaysian DCT guidance is established for the following EXCEPT

• Provide guidance on the implementation of DCT elements in clinical trials in Malaysia

• Provide general guidance for all sponsored research/ commercial studies that is intended for the purpose of product registration in Malaysia

• Recommend to be adopted for research that intends to apply any of the DCT elements mentioned in this document in Malaysia

• Provide a comprehensive and complete overview of all scenarios for implementing decentralized elements in a clinical trial in Malaysia

The following are the key considerations when conducting DCT in APAC region

• Regulatory complexity, cross cultural barrier, perception of DCT

• Regulatory complexity, cross-cultural barrier, financial considerations

• Cross-cultural barrier, financial considerations, and awareness

• Awareness, perception of DCT and regulatory complexity