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

The person obtaining the consent AND the Witness signatures

Question 10

Who must sign the actual Short Form?

Answer 10

Witness AND Trial Subject’s signature (or LAR)

Question 11

Can a clinical investigation be exempt from the IRB?

Answer 11

YES, only if: The following clinical investigations are exempt from IRB requirements:​

If the investigation commenced before July 27, 1981 provided that the investigation remains in compliance with all FDA requirements applicable at that time​

Emergency use of a test article as long as such use is reported to the IRB within 5 working days​

Certain food taste/quality studies

Question 12

An IRB may invite a subject matter expert to assist in the review of complex issues but that individual may not what?

Answer 12

VOTE

Question 13

True or False:

Does the FDA have authority to inspect IRB records, identify noncompliance and disqualify the IRB?

Answer 13

YES

Question 14

An informed consent document may not include any exculpatory language through which the subject releases or appears to release whom from liability or negligence?

Answer 14

The sponsor, clinical research organization and the institution or its agents

Question 15

During the clinical trial, regulations require that a subject be given the right to:​

Be informed of costs that they may incur​

Withdraw at any time without penalty​

Be told of significant new findings​

All of the above ​

Answer 15

All of the above ​

Question 16

The IRB must pay particular attention to ensure additional safeguards are taken for vulnerable subjects in federally supported research. Which of these groups are considered vulnerable? ​

A. Children, prisoners, pregnant women, mentally disabled persons ​

B. Mentally disabled persons, college students​

C. Economically or educationally disadvantaged persons​

D. A and C only​

E. All of the above

Answer 16

D. A and C only​

Question 17

Investigational product brochure:

Answer 17

The product itself, which may be a drug, supplement, or device.

Question 18

Investigator’s brochure:

Answer 18

A document that summarizes information about the IP, including clinical and nonclinical data. The IB is a dynamic document that is updated as new information becomes available.

Question 19

The Investigator Brochure should include:

Answer 19

A description of the IP’s drug substance and formulation
Information on the IP’s known effects in humans, including safety, efficacy, and pharmacokinetics
Summaries of completed clinical trials
Information on the IP’s use outside of clinical trials, such as during marketing
Instructions for using, maintaining, and storing the IP
Any information that will be included on the IP’s label

Question 20

Does the the Investigator Brochure need to be reviewed once approved?

Answer 20

yes, needs to be reviewed and validated at least once a year.

Question 21

1) *The responsibility for ensuring that the investigator understands a clinical trial lies with:

A. FDA​

B. IRB​

C. Sponsor​

D. Coordinator

Answer 21

C. Sponsor​

Question 22

What is the minimum number of IRB members?​
A. 3​

B. 5​

C. 6​

D. 10

Answer 22

B. 5​

Question 23

Significant risk device is defined as an investigational device that is:​

A. Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject.​

B. Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to the health, safety, or welfare of a subject.​

C. For a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject.​

D. All the above

Answer 23

D. All the above

Question 24

With respect to IRB/IEC membership, both the FDA and the ICH require that:

A. A majority of the members’ primary area of interest is in a scientific area​

B. At least one member holds a Ph.D. degree or equivalent​

C. At least one member’s primary area of interest is in a nonscientific area​

D. A majority of the members are from or have ties to the institution of record

Answer 24

C. At least one member’s primary area of interest is in a nonscientific area​

Question 25

What needs to be included in 1572 form?
a. Subject demographics
b. Data and Safety Monitoring Board membership
c. Investigator Financial interest/disclosure information
d. Investigator Brochure

Answer 25

a. Subject demographics

Question 26

A subject has been enrolled on a study and was randomized to the non-treatment arm. The protocol outlines study procedures for all subjects to be performed within one week of enrollment. Which of the following statements about this case is correct?​

A. This subject does not need to undergo any of the study procedures since the subject is enrolled on the non-treatment arm​

B. This subject should undergo all study procedures as outlined in the protocol​

C. This subject only needs to undergo the study procedures that pertain specifically to the subject​

D. This subject can undergo the study procedures whenever it is convenient

Answer 26

B. This subject should undergo all study procedures as outlined in the protocol​

Question 27

A purpose of monitoring clinical trials is to verify that:​

A. The rights, safety, and well-being of human subjects are protected​

B. Investigators receive adequate payment for their participation in the clinical trial​

C. The investigator has received annual reports from the sponsor​

D. The regulatory agency has received all case history information of subjects enrolled on the clinical trial

Answer 27

A. The rights, safety, and well-being of human subjects are protected​

Question 28

Which of the following is the proper way to make a correction to a CRF?
A. Completely blacken the incorrect entry and then enter the correct information​

B. Back date the corrected entry with the date of the original entry​

C. Initial using the initials of the sponsor’s representative who reviewed the change​

D. Add the initials of the person making the change, the date of the change, and, if necessary, a brief explanation of the change

Answer 28

D. Add the initials of the person making the change, the date of the change, and, if necessary, a brief explanation of the change

Question 29

The contents of a Protocol should generally contain:​

A. Trial objectives and purpose​

B. Assessment of efficacy​

C. Data handling and record keeping​

D. All of the above​

E. Only A & C

Answer 29

D. All of the above (Pg. 255)

Question 30

Only the principal investigator is allowed to transcribe data from the source document to the CRF?

A. True​

B. False

Answer 30

B. False ​

(pg. 240 - The sponsor should utilize qualified individuals (e.g., biostatisticians, clinical pharmacologists, and physicians) as appropriate, throughout all stages of the trial process, from designing the protocol and CRFs and planning the analyses to analyzing and preparing interim and final clinical trial reports.)

Question 31

Who monitors the progress of all clinical trial investigations being conducted under an IND?

A. Principal Investigator​

B. IRB​

C. Sponsor​

D. CRO

Answer 31

C. Sponsor (pg. 82 – 21CRF312 Subpart B)

Question 32

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

A. The Belmont Report​

B. The National Research Act​

C. The Nuremberg Code​

D. The Declaration of Helsinki

Answer 32

D. The Declaration of Helsinki (Pg. 201 – YEAR 1964)

Question 33

The Code of Federal Regulations that applies to Institutional Review Boards is:
​
A. 45CFR46​

B. 21CFR312​

C. 21CFR50​

D. 21CFR56

Answer 33

D. 21CFR56

Question 34

The international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects is known as…

A. The ICH​

B. Good Clinical Practices (GCP)​

C. The Declaration of Helsinki​

D. Fundamental Ethical Principles (FEP)

Answer 34

B. Good Clinical Practices (GCP) (Pg. 215)

Question 35

Each IRB that reviews studies involving children as subjects is covered by:

A. 21CFR Part 56, Sub part A​

B. 21CFR Part 56, Sub part B​

C. 21CFR Part 50, Sub part C​

D. 21CFR Part 56, Sub part D

Answer 35

D. 21CFR Part 56, Sub part D

Question 36

What is covered in 21CFR50 Subpart B?​

A. Informed consent of Human Subjects​

B. IRB Functions and Operations​

C. Records and Reports​

D. Additional Safeguards for Children in Clinical Investigations

Answer 36

A. Informed consent of Human Subjects​

Question 37

The IRB must determine that requirements for permission by parents or guardians and assent by children are met.
A. True​

B. False

Answer 37

A. True​

Question 38

What topic is covered in 45CFR46 Subpart B?​

A. Additional Safeguards and Protections​

B. Additional Protection for Prisoners and Vulnerable Subjects​

C. Additional Protection for Children and Unborn Fetuses​

D. None of the above

Answer 38

D. None of the above (Pg. 156 - Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research)

Question 39

Each IRB that uses an expedited review procedure must adopt a method for keeping all members advised of research proposals which have been approved under the expedited review procedure _________.

A. 45 CFR 46.110; CFR 56.110(c)​

B. 45 CFR 46.110(c); 21 CFR 56.110​

C. 45 CFR 46.110(c); 21 CFR 56.110(c)​

D. 45 CFR 46.110(b); 21 CFR 56.110(c)

Answer 39

C. 45 CFR 46.110(c); 21 CFR 56.110(c) (Pg. 148)

Question 40

In general, an AE observed during the conduct of a study should be considered an unanticipated problem involving risk to human subjects, and reported to the IRB, only if it were _________.
A. expected​

B. serious​

C. would have implications for the conduct of the study​

D. B & C​

E. A, B & C

Answer 40

D. B & C (Pg. 71 – 21CRF 56 Subpart C – IRB Functions and Operations)

Question 41

Once the sponsor evaluates data from a clinical trial and decides the drug presents an immeasurable and significant risk to the subjects; the sponsor has _____________ to discontinue the study.

A. 24 hours​

B. 48 hours​

C. 3 WD​

D. 5 WD

Answer 41

D. 5 WD

Question 42

According to 21 CFR 312.56, if a sponsor finds an investigator is non-compliant with a clinical protocol or approved investigational plan, the sponsor must:

A. Report the investigator to the IRB once it becomes aware​

B. Bring the investigator into compliance​

C. Immediately close that investigators site​

D. None of the above

Answer 42

B. Bring the investigator into compliance (Pg. 98 - 21 CFR 312.56)

Question 43

The Code of Federal Regulations part 50, 56 and 312 (among others) are designed to ensure the safety of clinical testing and the safety of products following a marketing approval.

A. True​

B. False

Answer 43

A. True​

Pg. 104 - 21 CFR 312.88

Question 44

The Food and Drug Administration (FDA) conducts drug risk assessment by considering which of the following?​

A. There are a sufficient number of people needing the drug.​

B. The benefits of the drug outweigh the known and potential risk of the drug​

C. The side-effects of the drug is measurable​

D. The sponsor is able to financially support the research

Answer 44

B. The benefits of the drug outweigh the known and potential risk of the drug (Pg. 103 - 21CFR 312.84)

Question 45

An investigational drug can be exported from the U.S., if​

A. Permission is granted by Congress​

B. The intended recipient is a US pharmacy​

C. The importer is a foreign pharmacy inspected and approved by the FDA​

D. Approval is granted after a written request is submitted to the FDAs International Affairs Staff Associate Commissioner.​

E. The drug is for investigational use only and goes directly to a potential patient

Answer 45

D. Approval is granted after a written request is submitted to the FDAs International Affairs Staff Associate Commissioner.​

Question 46

Emergency use of a test article is exempt from the requirement for IRB review, provided that such emergency use is reported to the IRB in writing within 5 calendar days.

A. True​

B. False

Answer 46

B. False​

Pg. 68 - Within 5 WORKING days; Study 21 CFR 56.104(c)

Question 47

A Clinical Hold is an order by FDA to the investigator to suspend or stop ongoing investigations.

A. True​

B. False

Answer 47

B. False (pg. 91 - to the Sponsor, not investigator. 21 CFR 312.42)

Question 48

An IND is always required before using an investigational new drug.

A. True​

B. False

Answer 48

B. False​

Pg. 75 - 21 CFR 312

Question 49

ALCOAC+

Answer 49

Attributable: The person or system that performed an activity should be recorded.

Legible: Data should be readable and understandable throughout its lifecycle.

Contemporaneous: Data should be documented at the time of the activity.

Original: The record should be original or a certified true copy.

Accurate: Data should be error-free and reflect what actually happened.

Complete: All original data and metadata should be collected.

Question 50

21 CFR Part 11

Answer 50

21 CFR Part 11 of the Code of Federal Regulations, overseen by the FDA, mandates that companies utilizing electronic records and signatures within regulated industries must implement controls to ensure the authenticity, integrity, and confidentiality of those records, including: limiting access to authorized users, maintaining detailed audit trails, validating systems to ensure accuracy, utilizing secure electronic signatures, and providing proper training for system users.

Question 51

Key component of 21 CFR Part 11

Answer 51

*Applies to regulated industries only

User Access Control:
Only authorized individuals should have access to electronic records, with unique login credentials and restrictions on account sharing.

Audit Trail:
A comprehensive record of all actions taken on electronic records, including creation, modification, deletion, and access attempts, must be maintained.

System Validation:
Electronic systems used for recordkeeping must be validated to ensure accuracy, reliability, and consistent performance.

Electronic Signatures:
Electronic signatures must be unique to each user, include date and time stamps, and be designed to prevent unauthorized modifications or repudiation.

Record Retention:
Electronic records must be stored and readily accessible for the required retention period.

Data Integrity:
Procedures to protect against data manipulation, accidental deletion, and unauthorized changes to electronic records.

Training Requirements:
All personnel using the electronic system must be adequately trained on relevant procedures and compliance expectations.

Question 52

Signed electronic records shall contain info associated with the signing that clearly indicates all the following:

Answer 52

The printed name of the signer​

The date and time when the signature was executed​

The meaning (such as review, approval, responsibilities, or authorship) associated with the signature

Question 53

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 53

All of the above

Question 54

Documents to be on file before trial starts at BOTH investigator & sponsor sites:

Answer 54

Investigator’s brochure​

Signed protocol & amendments (sample CRF if available)​

ICF​

Financial agreement​

Statement of insurance ​

Signed agreement between involved parties​

Approval from IRB for all essential documents​

CV of investigators​

Lab Normal Ranges​

Lab Certification

Shipping records for all trial materials​

Decoding procedure for blinded trials (to document how identity of blinded product can be revealed without breaking blinding for remaining subjects in case of emergency)​

Initiation monitoring report

Question 55

Before the clinical phase of the trial commences, which of the following essential documents is required to be located in the investigator’s files only? (select all that apply)

a) signed ICFs​
b) source documents​
c) subject identification code list​
d) subject enrolment log​
e) advertisement for recruitment

Answer 55

e) advertisement for recruitment 8.2.3

Question 56

During the clinical conduct of the trial, which of the following essential documents is required to be located in the investigator’s files only?​
​
a) audit certificate​
b) certificate of analysis for new batches of investigational products​
c) final trial close-out monitoring report​
d) subject identification code list​
e) treatment allocation and decoding documentation

Answer 56

d) subject identification code list​
​
8.3.21

Question 57

After Trial Completion:
Both Sponsor & Investigator site need to have what?

Answer 57

Clinical study report & investigational device final disposition

Question 58

After Trial Completion:
Only the sponsor needs to have what?

Answer 58

Final trial close-out monitoring report, treatment allocation & decoding​

Question 59

After Trial Completion:
Only the Investigator needs to have what?

Answer 59

Completed identification code list

Question 60

After completion or termination of the trial, which of the following essential documents is required to be located in the investigator’s files?​
​
a) audit certificate​
b) final trial close-out monitoring report​
c) treatment allocation and decoding documentation​
d) completed subject identification code list

Answer 60

d) completed subject identification code list​
​
8.4.3

Question 61

A sponsor’s audit is for internal use and therefore a copy is not usually given to the investigator audited.​
​
true​
false

Answer 61

True 8.4.4

Question 62

GCPs encompass all aspects of a clinical trial including (but not limited to):​
(mark all that apply)​
​
a) obtaining informed consent​
b) documenting accurate case histories​
c) maintaining complete “paper trails” for all study documents​
d) reporting adverse events​
e) proper record retention

Answer 62

a, b, c, d, e​
​
Protecting Study Volunteers in Research (Additional study material)

Question 63

There are few differences between the FDA and the ICH standards. If a protocol meets ICH guidelines, it will meet FDA requirements.​
​
true​
false

Answer 63

True!

Question 64

During the clinical conduct of the trial, which of the following essential documents ​

is required to be located in the investigator’s files?​

a) Audit certificate​

b) Certificate of analysis for new batches of investigational products​

c) Final trial close-out monitoring report​

d) Source documents​

e) Treatment allocation and decoding documentation

Answer 64

d) Source documents​

8.3.13