ICH Gap Analysis

Question 1

What does DSMB stand for?

Answer 1

Data and Safety Monitoring Board

Question 2

What is the primary purpose of a Phase I study?

Answer 2

To determine the metabolic and pharmacologic action of the drug in humans

Question 3

What is the purpose of the Data and Safety Monitoring Board (DSMB) ?

Answer 3

To assess the progress of a clinical trial, the safety data, and the clinical efficacy endpoints.

Question 4

What does hte IRB/IEC evaluate?

Select all that apply

1. The subject-selection procedure
2. The scientific tenability of hte trial
3. The rights, safety, and well-being of the subjects participating in the trial
4. The contract between teh sponsor and investigator

Answer 4

1, 2, 3

Question 5

What is the purpose of the initiation visit?

Select all that apply

1. To review the protocol
2. To review standard procedures
3. To review the blank Case Report Forms (CRFs)
4. To carry out source document verification

Answer 5

1, 2, 3

Question 6

Who is ultimately responsible for Source Data Verification (SDV)?

Answer 6

the monitor

Question 7

Most typical study, investigates human pharmacology. It is the initial administration or an investigatinal new drug into humans. It is most commonly done in healthy subjects.

Answer 7

Phase 1

Question 8

Providing a unified standard for Europe, US, and Japan to facilitate the acceptance of clinical trials is the…..

Answer 8

Mission statement of the ICH

Question 9

An investigator can be defined as….

Select all that apply

1. A person responsible for writing the trial protocol.
2. A person responsible for the conduct of the clinical trial at the trial site
3. The responsible leader of the clinical resarch team at the site and may be called the principal investigator.
4. A person responsible for the conduct of the clinical trial with the sponsor.

Answer 9

2 and 3

Question 10

A sub-investigator can be defined as….

Answer 10

Any individual member of ht eclinical trial team designated and supervised by the investigator at a trial site to perform clinical trial-related procedures and/or to make important trial-related decisions.

Question 11

According to the principles of ICH GCP…

Select all that apply

1. Chilical trials should be conducted in accordanece with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
2. The available nonclinical and clinical informaiton on an investigational product should be adequate to support the purposed clinical trial.
3. Before a trial is initiated, forseeable risks and inconveniences should be weighted against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
4. Clinical trials should be scientifically sound, and described in a clear, detailed protocol.

Answer 11

1, 2, 3, and 4

Question 12

Which of the following should the investigator do if a Serious Adverse Event (SAE) occurs?

Select all that apply

1. Inform the IRB/IEC, if required by local regulations.
2. Report it to the monitor during the next study visit.
3. Inform the sponsor immediately.
4. Discontinue the subject from the study.

Answer 12

1 and 3

Question 13

After an SAE has occurred, how should a subject identification occur on the immediate and follow-up records?

A. By the subject identification number

B. By their name

C. By a unique code for serious Adverse Event (AE) reporting

D. By their address.

Answer 13

A. By their subject identification number.

Question 14

In the event of a subject’s death, what additional information shoudl be supplied to the sponsor?

Select all that apply

1. The address of the next of kin so that the sponsor can write a letter of condolence.

B. The name and address of the subjet’s general practitioner

C. Terminal medical reports, if available

D. An autopsy report, if available

Answer 14

C and D

Question 15

What documentation should be supplied to the sponsor before the study?

Select all that apply

1. The completed subject informed consent forms.
2. The CVs of all investigators and other study personel who are significantly involved in trial related duties.
3. The signed contract between sponsor and investigator.
4. The completed Case Report Forms (CRF)

Answer 15

2 and 3

Question 16

What details need to be documented in the subject notes when the AE occurs?

Select all that apply.

!. What the subject thinks caused the event.

2. When the event occurred.
3. The severity of the event.
4. No documentation is necessary.

Answer 16

2 and 3

Question 17

Who is responsible for the appropriate monitoring of clinical trials?

Answer 17

the sponsor

Question 18

During the trial, who is responsible for communicating with the IRB/IEC?

Answer 18

the investigator

Question 19

Which of the following individuals could be members of an IRB/IEC?

Select all that apply

1. Trial Subjects
2. Medical professionals
3. Lay people
4. The sponsor

Answer 19

2 and 3

Question 20

In which format shoudl approval be received from the IRB/IEC?

Answer 20

Written

Question 21

Which of the following criteria is described in ICH’GCP as necessary for classifying an Adverse Event (AE) as an Adverse Drug Reaction (ADR)?

A. That a causal relationship is a strong possibility

B. That a causal relationship is a very strong possibility

C. That a causal relationship is a definite possibility

D. That a causal relationship is at least a reasonable possibility.

Answer 21

D. That a causal relationship is at least a reasonable possibility.

Question 22

What information needs to be included in the subject’s medical records?

Select all that apply.

Medical history

Randomization number

Occurrence of any AEs

Name of the monitor

Answer 22

Medical history

Randomization number

Occurrence of any AEs

Question 23

Which groups of potential subjects are mentioned in ICH-GCP as being ‘vulnerable subjects’?

Select all that apply.

1. Employees of the pharmaceutical industry
2. Junior members of the medical profession
3. People with heart conditions
4. Members of the armed forces

Answer 23

1, 2, and 4

Question 24

Who conducts clinical resaerch Quality Control (QC) activities?

Answer 24

Monitor

Question 25

According to the Declaration of Helsinki, physicians may use an unproven intervention. TRUE OR FALSE? I think true but need to check somewhere

Question 26

What is the minimum amount of time after formal discontinuation of the clinical development of an investigational product that essential documents should be retained according to ICH-GCP?

Answer 26

2 years after the last marketing application approval in an ICH-GCP region

Question 27

Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and it cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the resarch. TRUE or FALSE ?

Answer 27

TRUE

Question 28

A candidate presents him/herself for a monitor position. What qualifications should the potential monitor be able to provide proof of to be considered for the position? Select all that apply. 1. Have the clinical knowledge needed to monitor a trial. 2. Have the scientific knowledge needed to monitor a trial. 3. Be familiar with GCP 4. A bachelor degree

Answer 28

1, 2, and 3 Reference: ICH E6 section 5.18.2

Question 29

A monitor is tasked to select investigators for a new upcomig oncology trial. What evidence of qualifications should the potential investigator be able to provide to be considered for the conduct of the trial? Select all that apply. 1. A university degree 2. Evidence of awareness of and compliance with GCP and the regulatory requirements. 3. A log of training records of all trial specific training the investigator ever took. 4. An up to date CV, showing evidence of adequate education, training, and experience.

Answer 29

2. Evidence of awareness of and compliance with GCP and the regulatory requirements. 4. An up to date CV, showing evidence of adequate education, training, and experience.

Question 30

A subject visits the investigator at the scheduled visit window in her office as an outpatient and reports he suffers from a fever after being treated by the Investigational Product (IP) for a week. Is this occurrence an AE or an SAE?

Answer 30

This is an AE becuse it can be classified as an untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Question 31

An experienced research coordinator was asked to train a new junior clinical trial team member on safety reporting. What should she train on? Select all that apply. 1. Report Unexpected Serious Adverse Drug Resactions (SUSARS) as per the applicable regulatory requirements. 2. Supply the sponsor and the IRB/IEC with any additional requested infomraitonf or any reported deaths. 3. Supply the IRB/IEC with a summary of all AEs and SAEs on a monthly basis. 4. All subjects shouldl be identified by unique code numbers rather than by the subject's name.

Answer 31

Don't know....

Question 32

When is verbal consent prior to participation in a research study permitted?

Answer 32

When the subject is illiterate.

Question 33

Which signatures are required by ICH Guidelines to be on the Informed Consent Form? Select all that apply. 1. the investigator 2. the subject 3. the person who conducted the infomred consent discussion 4. the investigator and the subject

Answer 33

2 and 3

Question 34

For the investigational drug studies, the sponsor must provide the investigators with the: Select all that apply. 1. Full Investigational New Drug Application (IND) 2. Latest package insert 3. Safety surveillance updates 4. Investigator brochure

Answer 34

Don't know....

Question 35

Whose responsibility is it to safeguard the rights and safety of subjects in clinical trials? Select all that apply. 1. The investigator 2. The sponsor 3. The IRB.IEC 4. The subjects' general practitioner

Answer 35

1, 2, and 3 the investigator the sponsor the IRB.IEC

Question 36

Who does hte investigator need to inform if he/she deviates from the protocol? Select all that apply. 1. The regulatory authorities 2. The sponsor 3. The IRB.IEC 4. The office staff

Answer 36

1, 2, and 3 The regulatory authorities The sponsor The IRB/IEC

Question 37

Who should have access to the trial files? Select all that apply 1. The subject 2. The investigator 3. The pharmacist 4. The monitor

Answer 37

2. The investigator 4. The monitor

Question 38

An AE that is sever in intensity

Answer 38

May not meet the definition of serious

Question 39

A subject in its third trial week in an oncology trial at a hospital site asks the investigator during a follow-up visit for some clarifications on the Investigational Product (IP) dosage used. The investigator refers the subject to the pharmacist for more informaiton as (s)he claims not to know the details of how to use th IP. Is this answer in compliance with the GCP E6 guideline?

Answer 39

No. The investigator should be thoroughly familiar with the appropriate use of the IP as described in the protocol and the current Investigator's Brochure and should explain the correct use to and do periodic checks for understanding compliance with the subject.

Question 40

The subject arrives for the informed consent interview, but the investigator has no more informed consent forms. What should the investigator do? Select all that apply 1. Write the details on a blank piece of paper. 2. Photocopy another subject's form and use correction fluid to remove the details. 3. Have already made sure that there were enough forms before the interview. 4. Ask the subject to come back.

Answer 40

3. Have already made sure that there were enough forms before the interview. 4. Ask the subject to come back.

Question 41

A site is being renovated and no longer has adequate storage space to hold all of the past studies it has conducted. Some studies are older than 20 years. Some Investigational Products (IPs) are now marketed. How can the site determine which files it still needs to store?

Answer 41

Contact the sponsor for each trial to ask for a letter outlining instructions for disposition of records.

Question 42

An investigator wants to enroll a diabetes patient into a clinical trial. The inclusion criteria require results of blood tests to confirm general status of diabetes. What lab results can be used to check compliance with the inclusion criteria? Select all that apply 1. The lab results as part of the normal medical practice after the ICF was signed. 2. The lab results after the ICF was signed. 3. The lab results before the ICF was signed. 4. The lab results as part of the normal medical practice before the ICF was signed.

Answer 42

1, 2, and 4

Question 43

A monitor is making corrections on the CRFduring a monitoring visit and asks the site staff (as identified on the signature and delegation log) to sign and date these corrections. This is an accepted way of working because:

Answer 43

It does not matter who makes the corrections on the CRF (sponsor representatives or site staff identified on the signature and delegation log) as long as they are made when necessary, endorsed by the investigator, and documented.

Question 44

In general, unused investigational drugs:

Answer 44

Must be returned to the sponsor.

Question 45

Who may have direct access to the subjects' medical records? Select all that apply 1. All those named in the informed consent form signed by the subject. 2. All qualified hospital staff. 3. The investigator by default 4. The monitor by default.

Answer 45

1. All those named on the informed consent form signed by the subjects 3. The investigator by default.