To ensure the well being and safety of the study subjects

Conduct the informed consent process in a suitable environment

To falsify the study data to ensure the findings favarouble towards the IP

Only recruit study participants who are eligible to be included

True

False

To add on unnecessary burden for the PI to conduct the clinical trials

To ensure that reported trial data are accurate and verifiable from source documents.

To ensure the rights and well-being of human subjects are protected.

To ensure that the conduct of the trial is in compliance with the approved protocol

The sponsor should provide insurance or should indemnify the investigator

Provide adequate funding to ensure the sustainability of the study

To conduct a clinical trial without involvement of any clinicians

  To select experienced, qualified and suitable clinicians as the PI

A sponsor may transfer any of the sponsor's trial-related duties to a service provider

All references to a sponsor in this guideline also apply to a service provider

Trial-related duties not transferred to by a service provider are retained by sponsor

Service providers should be biased towards the sponsor as they are employed by them

True

False

Hospital records

Photostated ECG of the study participants

Laboratory notes and results

X-ray or CT films

Good Medical Practice

Good Machinery Practice

Good Medicinal Product

Good Manufacturing Practice

reduce the harm and adverse event of the study participants in any trials

respect participants ability to make decision in their research involvement

upheld the duty to ensure the best interest of the participants

decide for the sake of the study result disregarding the participant safety

authorizes the licensee to manufacture any local product for trials

authorizes licensee to import any product for purposes of clinical trials

authorizes the licensee to start conducting the clinical trials

authorizes the applicants to amend any trial related documents

to the IRB/IEC for review and approval/favourable opinion

to the sponsor for agreement

there is no need to submit the proposed protocol amendments

to the regulatory authority(ies)

those aspects of the trial that are experimental

the anticipated payment or reimbursement

The participation in the study is compulsory

the purpose of the study

no need to be updated if there are any new updates available

is not the duty of the sponsor to prepare the study document in the industry-sponsored research

contains the personal details of the study participants

is a compilation of the clinical and nonclinical data on the IP that are relevant to the study of the products in human subjetcs

a) i, ii, iii, iv

b) i, ii, iii

c) i, ii, iv

d) i, iii, iv

i, ii, iii, iv

i, ii, iv

i, iii, iv

i, ii, iii

The representative of the study sponsor

The study coordinator

The study nurse

The matron who works in the ward and not involved in the study

Any revised written consent form must receive ethical committee’s approval

The written consent form should be signed and personally dated by the subject or by the subject’s legally acceptable representative

Impartial witness can be anyone who is directly or indirectly involved in the study

Neither the investigator, nor the trial staff should coerce or unduly influence a subject to participate in a clinical trial

The anticipated prorated payment, if any, for the subjects

The reasonably foreseeable risks or inconveniences to the subjects

It is compulsory for the subject to participate in the clinical trial in order to get the essential treatment for the conditions

The trial procedures to be followed, including all invasive procedures

i, ii, iii, iv

i, ii, iv, v

i, iii, iv, v

i, ii, iii, v