KT1

Question 1

what is development of trial protocol?

Answer 1

• The sponsor, often in consultation with one or more clinical investigators, generally designs the study protocol;
• Clinical investigators may also design and initiate clinical studies, as sponsorinvestigators.
• The sponsor and clinical investigator(s) should be aware of any national/local laws or regulations pertaining to designing, initiating, and conducting the study

Question 2

what is the development of SOP?

Answer 2

sop : Detailed, written instructions to achieve uniformity of the performance of a specific function
- All parties who oversee, conduct or support clinical research should develop and follow written standard operating procedures (SOPs) that define responsibilities, records, and methods to be used for study-related activities.

Question 3

what is Development of support systems and tools?

Answer 3

Appropriate support systems and tools facilitate the conduct of the study and collection of data required by the protocol
- computer hardware and software
- electronic patient diaries
- trial-related documents
- The sponsor is generally responsible for developing, maintaining, modifying and ensuring the availability of
support systems and tools for conducting the trial and collecting and reporting required data.

Question 4

what is Generation and approval of trial-related documents?

Answer 4

Development of trial-related documents may facilitate the conduct of the study, collection and reporting of study-related data, and analysis of study results.
– The sponsor generally develops, designs, and provides various standardized forms and checklists to assist the clinical investigator and his/her staff in capturing and reporting data required by the protocol.

Question 5

what is Selection of trial sites and the selection of study team?

Answer 5

Clinical investigators must be qualified and have sufficient resources and appropriately trained staff to conduct the investigation and be knowledgeable
of the national setting and circumstances of the site and study population(s).
– Sponsors should review the requirements of the study protocol to determine the type(s) of expertise required and identify clinical investigators who have the
particular medical expertise necessary to conduct the study and who have knowledge, training and experience in the conduct of clinical trials and human
subject protection

Question 6

what is Ethics committee review and approval of the protocol?

Answer 6

• Within GCP, studies must be reviewed and receive approval/favourable opinion from an Independent Ethics Committee (IEC)/Institutional Review Board (IRB)
  prior to enrolment of study subjects.
  – The investigator generally assumes responsibility for obtaining IEC/IRB review of the study protocol.
  – Copies of any approval/favourable opinion are then provided to the sponsor.

Question 7

what is Review by regulatory authorities?

Answer 7

Within GCP, studies must undergo review by regulatory authority(ies) for use of the investigational product or intervention in human subjects and to ensure
that the study is appropriately designed to meet its stated objectives, according
to national/regional/local law and regulations.
– The sponsor is generally responsible for ensuring that the applicable regulatory authority(ies) review and provide any required authorizations for the study before the study may proceed.
– The sponsor should also list the trial in applicable and/or required clinical trial
registry(ies).

Question 8

ct regulatory process?

Answer 8

drug : CTA/CTN, CTC, CRM (import license)

non-drug : CRM