Electronic records, ​ ICH Principles, ICH Responsibilities of IRB/IEC, and Investigators

Question 1

The World Medical Association (WMA) ethical principles for medical research involving human subjects is called…

Answer 1

The Declaration of Helsinki is the correct answer because it is a set of ethical principles established by the World Medical Association (WMA) for medical research involving human subjects.

Question 2

Choose all that applies: What are the requirements of an electronic signature?
Unique to one individual and not reused​

Identity of the individual is verified before an organization assigns or certifies the e-signature​

Certify that the e-signatures are legally binding equivalent of handwritten signatures ​

All of the above

Answer 2

All of the above

Question 3

The FDA guidelines from (Which PART) help establish accountability and traceability throughout your documentation processes?

Answer 3

Part 11

Question 4

Vulnerable Subjects

Answer 4

Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the ​

expectation, whether justified or not, of benefits associated with participation, or of a retaliatory ​

response from senior members of a hierarchy in case of refusal to participate. ​

Examples:​

Members of a group with a hierarchical structure: ​

medical, pharmacy, dental, and nursing ​

students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. ​

Other vulnerable subjects:​

patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

Question 5

Specify information that the investigator should promptly report to the IRB/IEC
A. Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial subjects ​

B. Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial​

C. All adverse drug reactions (ADRs) that are both serious and unexpected.​

D. New information that may affect adversely the safety of the subjects or the conduct of the trial.​

E. All the above

Answer 5

E. All the above

Question 6

Blinding (masking):

Answer 6

Withholding information about assigned interventions from one or more parties involved in the research study.

Question 7

Unblinding:

Answer 7

The process of revealing which treatment a participant received during the trial.

Question 8

True or False: When a short form is used for Informed Consent, the witness must sign either the short form or the summary.

Answer 8

False​
​
Why: They must sign both

Question 9

Who must sign the summary of the Short Form?

Answer 9

2, The person obtaining the consent signature and the Witness signature

Question 10

Who must sign the actual Short Form?

Answer 10

Witness and Trial Subject’s signature