To fulfill regulatory obligations to IRB/IEC or RA

To comply with the protocol

To ensure systems are designed to permit data changes

To ensure appropriate accountability / storage / use of Investigational Product is maintained

To obtain and document informed consent

The subject is informed about the trial after she/he has signed the Inform consent

The inform consent process is a process Process by which a subject voluntary confirms, her/his willingness to participate to trial after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate

The inform consent process is a process Process by which a subject voluntary confirms, her/his willingness to participate to trial. After what the subject will be informed of all aspects of the trial that are relevant to the subject’s.

True

False

Monitor should maintain the essential documents

Monitor should be appointed by the Sponsor

Monitors should obtain the Ethics Committee approval to have access to source documents

Monitor should determine that all adverse events are appropriately reported

Conduct of Clinical trials in accordance with ethical principles, GCP and applicable regulatory requirements.

Individuals involved in conducting a trial do not need to be qualified by education, training and experience.

The rights, safety and well-being of subjects are the most important considerations.

Freely given informed consent should be obtained from most subject prior to clinical trial participation.

Freely given informed consent should be obtained from every subject prior to clinical trial participation.

Vulnerable research populations require special protection.

Investigations should be ceased if the risks are found to outweigh the potential benefits.

Participation in a trial must be voluntary and participants must be informed.

Physicians should obtain freely-given informed consent from each participant.

ICH - GCP renforces tight guidelines on : Ethical aspect and scientific aspect

ICH - GCP renforces tight guidelines on : Ethical aspect and standards (comprehensive documentation, record keeping, …)

Vulnerable subjects may not have received the required special protection.

Investigations were not ceased after the risks were found to outweigh the potential benefits.

Participants had not been adequately informed.

Post-trial access arrangements were insufficient.

Death

Life-threatening

Broken leg

Persistent or significant disability/incapacity

Congenital anomaly/birth defect.

Stratified randomization means randomizing subject by flipping a coin

Stratified randomization is a two-stage procedure, first the subject are grouped into strata than they are randomized.

The purpose is to test efficacy of the investigational drug and to monitor adverse reactions

The purpose is to evaluate drug safety safety and drug dosage dosage

The Investigator brochure is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial.

The Investigator brochure is a compilation of the clinical and nonclinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects

The Investigator brochure is a  contains detailed, written instructions to achieve uniformity of the performance of a specific function.

RBM focuses on study critical  processes to enhance trial cost reduction.

RBM focuses on study critical data and processes to enhance protection of human subjects as well as study quality

The controller is the organization which alone or jointly with others, determines the purposes and means of the processing of personal data

The controller is the organization which processes personal data on behalf of the controller

GDPR is the EU’s data protection regulation that prescribes requirements for: Collecting, Processing, Storing Personal Data of individuals

Vulnerable subjects may not have received the required special protection.

Investigations were not ceased after the risks were found to outweigh the potential benefits.

The population where the research was carried out is unlikely to benefit from the study. the physician should

Post-trial access arrangements were apparently lacking.

Consent may not have been fully informed and freely-given

Site Courtesy Visit

Site Evaluation/Qualification Visit

Site Close-Out Visit

Site Initiation Visit

Site Evaluation/Qualification Visit

The market development will generate $$$

The rights, safety and well-being of trial subjects are protected

The clinical trial data are credible.

The data will safe

After obtaining consent

after the randomization of the patient

Prior to the subject's participation in a clinical trial and any study specific related procedures

Before obtaining consent

A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, Sponsor's SOPs, GCP, and the applicable regulatory requirement(s)

The act of overseeing the process of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP and the applicable regulatory requirement(s)

Individual, company, institution or organization which takes responsibility for the initiation, management and/or financing of a clinical trial