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WorksheetsQuiz TIPS Part 2/2023
Total questions: 9
Worksheet time: 5mins
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
