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SOCRA Prep 2024 > ICH Overview > Flashcards

ICH Overview Flashcards

1
Q

Why was there a need for the International Conference on Harmonisation (ICH) in the early 1990s? What is the primary goal of ICH E6?

A

To reduce the time, money and redundant testing for drug marketing registrations in different countries.

The ICH standards on all aspects related to drug + biological investigations aim to make it more feasible for drugs to be marketed by countries and studies who adopt the guidelines.

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2
Q

What is the role of compliance with Good Clinical Practice (GCP) standards according to ICH E6?

A

Adhering to GC standards enhancing the protection of human subjects involved in research and improves the integrity of the data/findings and the study

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3
Q

What are the main categories covered by ICH guidelines and what are brief explanations?

A

Safety: topics that involve in vitro and in vivo pre-clinical studies
Multidisciplinary: topics that don’t fit into the other categories
Efficacy: topics involving human research
Quality: quality assurance for chemical and pharmaceutical topics

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4
Q

What is an adverse event?

A

It is an unintended and unfavourable sign, symptom, or disease/condition that may or may not have a causal relationship to the pharmaceutical product

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5
Q

What are the 13 principles of ICH GCP E6?

A
  1. Ethics - the investigational study must be conducted in an ethical manner that follows the principles of the deflation of Helsinki, the ICH GCP and the applicable regulatory requirements
  2. The risks are justified by the benefits and they are weight against each other
  3. Humans/participants are prioritized over the investigational trial
  4. Support - sufficient non clinical and clinical evidence to move on to the clinical trial
  5. Medicinal decisions are made by licensed physicians and dentists
  6. The study has IRB/IEC approval before starting any study activities
  7. Participants sign an informed consent form prior to joining
  8. Science is sound and integrity is upheld
  9. Qualifications: investigative team has the proper training, experience, etc
  10. Quality - high quality standards
  11. Confidentiality of participants is protected
  12. The information is handled and stored in a way that preserves it’s integrity
  13. GMP - manufacturing, storage, etc of pharmaceutical product is done according the the GMP
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6
Q

Per ICH GCP E6, what are the responsibilities of the IRB?

A
  1. To ensure that clinical investigations are in compliance with ethical principles such as the declaration of Helsinki, ICG GC and applicable regulation requirements
  2. To request and review specific documentation from each trial, such as (protocol, ICF, recruitment materials, additional information given to participants, IB + safety information, CV of principal investigation, compensation/incentive, and other additional documents)
  3. After initial review, the IRB/IEC must continue reviewing investigations AT LEAST once a year
  4. IRB/IEC must provide to investigator/sponsor written notice of their review decision (.e.g approval, request for modification, disapproval, or suspension). In the notice they must include the name, date and docs reviewed.
  5. Must review the CV and qualifications of the PI to ensure they are qualified enough
  6. If a legal representative of a subject provides consent for them to be part of a study that does not directly benefit them, the IRB must ensure that the protocol addresses all ethical concerns and adheres to regulatory requirements
  7. If a study proposes that the legal representative or the subjects cannot provide informed consent, the IRB/IEC has to make sure the protocol and other docs address ethical concerns and adhere to applicable regulator requirements
  8. Evaluate amount and method of compensation to ensure no coercion or undue influence.
  9. Compensation has to be prorated
  10. Amount, method and interval of payment have to be included in the ICF/other important documentation for the participant (e.g. pamphlet)
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7
Q

What are the 2-3 IRB responsibilities criteria that are shared between CFR and ICH GCP?

A
  1. Requirement to review approved studies on an on going basis AT LEAST once a year. Frequency is determined by risk of study.
  2. Providing written notice of review decision (approval, modification request, disapproval) to sponsor and investigator
  3. Both mention situations where the IRB may not require a study to obtain consent from a legal representative and/or subject. But CFR mentions that there are two situations where a study might be eligible, whereas, ICH states that the IRB/IEC must ensure the protocol addresses all ethical concerns and adheres to applicable regulatory requirements
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8
Q

Who is allowed to vote or provide opinions on trial-related matters within the IRB/IEC per ICH GCP?

A

Only members who were part of the review/discussion

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9
Q

Per ICH GCP, What is the investigator’s role during the IRB/IEC deliberations?

A

To provide insight about the clinical investigation

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10
Q

Per ICH GCP, suppose an investigator wishes to make a minor logistical change to the trial protocol, such as updating contact information. What steps should the investigator follow, and what role does the IRB/IEC play in this situation?

A

The investigator can make those changes to the approved document without IRB approval first. They should submit for approval in the next amendment/modification.

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11
Q

A trial subject experiences a serious and unexpected adverse drug reaction (ADR). Describe the reporting obligations of the investigator to the IRB/IEC (per ICH GCP)

A

The trial must immediately report any unexpected and serious ADR to te IRB/IEC per ICH/GCP.

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12
Q

You are a member of an IRB/IEC, what are the reporting guidelines you need to communicate and enforce to the trials that you are managing according to ICH GCP?

A
  • investigator needs to submit for approval any changes to the protocol before proceeding unless they need to be done immediately to reduce harm to a participant or it is a minor logistical/administrative change
  • the investigator needs to immediately report any of the following:
    A) use of investigational product to reduce the immediate risk/harm to a participant
    B) serious and unexpected adverse drug reaction
    C) changes or new information that affects the risk, safety and/or conduct of the study
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13
Q

As a member of the IRB, what procedures related to the members can you expect to follow? (ICH GCP)

A
  • determining the composition (name + qualifications) of the members and the hierarchy of authority
  • being responsible for communicating with members about scheduling, meetings, decisions, etc
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14
Q

Imagine you are an investigator planning to conduct a clinical trial. According to ICH GCP guidelines, what is your responsibility regarding the delegation of significant trial-related duties?
A) You should handle all duties personally.
B) Delegation is not allowed.
C) Delegation is permitted, and you should maintain a list of appropriately qualified persons.
D) You are not required to delegate any duties.

A

C

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15
Q

You are about to conduct a clinical trial and need to demonstrate your ability to recruit subjects. What does ICH GCP recommend you should be able to show?
A) The ability to recruit subjects from a specific demographic.
B) A potential for recruiting any number of subjects.
C) A potential for recruiting the required number of suitable subjects within the agreed recruitment period.
D) No specific demonstration is required.

A

C

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16
Q

In a scenario where a subject is withdrawing prematurely from your trial, how should you, as an investigator, handle the situation according to ICH GCP?
A) No effort is needed to ascertain the reason; subjects are not obliged to give reasons.
B) Make a reasonable effort to ascertain the reason while fully respecting the subject’s rights.
C) Withdrawal reasons are irrelevant to the trial.
D) Disclose the subject’s reasons to the IRB without their consent.

A

B

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17
Q

In the context of clinical trial adverse events, what role does the investigator play according to ICH GCP?
A) Adverse events are solely the responsibility of the sponsor.
B) Ensure adequate medical care for events related to the trial.
C) Document adverse events without taking any further action.
D) Investigator involvement is optional and depends on the severity.

A

B

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18
Q

When preparing for a clinical trial, what level of familiarity does ICH GCP expect an investigator to have with the investigational product?
A) Basic knowledge of the product’s general category.
B) Familiarity only with the trial protocol.
C)Minimal knowledge is sufficient.
D) Thorough familiarity with the investigational product’s appropriate use.

A

D

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19
Q

In the context of investigator qualifications, what documentation does ICH GCP recommend investigators provide to demonstrate their qualifications?
A) A brief self-attestation statement.
B) A statement from the sponsor confirming qualifications.
C) A comprehensive curriculum vitae and/or relevant documentation.
D) Qualifications need not be documented.

A

C

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20
Q

In a hypothetical scenario, you are an investigator conducting a non-therapeutic trial, and you are considering subjects who cannot give informed consent personally. According to ICH E6, under what conditions could such subjects be included in the trial?

A

If the legal representative can provide consent, subjects should be included if:
- the study cannot be done on a population that can provide consent
- the study has minimized the risk/burden on the subjects and it is low
- the study is not prohibited by law
- the IRB has approved the study and the selection of this population

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21
Q

In a real-world scenario, you are the investigator of a clinical trial, and an emergency situation arises where prior consent is not possible. According to ICH E6, what measures should you take to protect the rights, safety, and well-being of the subject?

A
  • attempt to obtain consent from the legal representative.
  • If this is not possible, the study should have IRB approval for proceeding with emergency use of the pharmaceutical product when it cannot obtain consent.
  • the investigators also need to do everything they can to contact and inform the legal representative and obtain their consent
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22
Q

According to ICH GCP, what should investigators aim to do for subjects that cannot provide their written consent (children, detention) and must have a legal preventative do it?

A

Investigators must attempt to explain the study to the extent that makes sense with that subject and also obtain written consent from that subject (if possible). E.g. assent

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23
Q

Per ICH GCP, whose responsibility is it to provide annual status reports to the IRB? What about if significant changes are made to the study where it is impacting the risk of the subjects and conduct? Who do they need to inform as well?

A

Per ICH GCP, it is the investigators responsibility to submit status reports to the IRB per their established frequency of reporting.

It is also the investigators role to submit reports of changes to the sponsor, IRB/IEC or sponsor of changes that significantly impact the risk and conduct of the study.

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24
Q

What is a case report form?

A

A CRF is a place to record the variables/data that are specified in the protocol

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25
Q

According to ICH GCP, what is the timeline to keep Essential Documents? What are the conditions that affect the storage timeline? Whose responsibility is it to keep these documents?

A

2 years from the last approval received from a drug marketing application (e.g. NDA) and if there are no more pending applications ICH region

OR

2 years from when the clinical trial was discontinued (e.g. nowshine)

It is the Investigators responsibility to keep these documents according to ICH GCP and any applicable regulatory requirements.

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26
Q

According to ICH E6, what responsibilities does the investigator have regarding the collection, documentation and amendment to the data collected for the trial?

A

The investigator must adhere to ALCOA+C (attributable, legible, contemporaneous, original, accurate and complete) principles when documenting the data.

There should be an audit trail for changes to data on paper or electronic formats. The original “entries” should not be obscured or removed.

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27
Q

In accordance with ICH E6 (4.9.2), what does the guideline recommend when discrepancies exist between data reported on Case Report Forms (CRFs) and source documents?

A

Data copied from source documents to CRFs should be done carefully to match. If there are discrepancies, they should be explained (e.g. in SCM when different notes specified different administered meds, we should record all data charted)

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28
Q

Imagine you are an investigator who completed an FDA regulated trial and received NDA approval, according to ICH E6, how long should you retain your essential documents for? Are there any other regulations to abide by?

A

For a minimum of 2 years after the approval, as long as there are no more pending drug marketing applications AND per the CFR and other applicable regulatory requirements for storage (2 years for investigators and sponsors per CFR).

29
Q

What should the investigator do in the event of a prematurely terminated or suspended trial without prior agreement of the sponsor? (Per ICH GCP)

A

They should first let the institution know —> investigator/institution let the sponsor and IRB/IEC know and provide them with a written explanation/report

30
Q

In case of a reported death during the trial, what additional information may be asked of the investigator to supply the sponsor and IRB/IEC? (Per ICH)

A

Additional information may include autopsy reports, medical reports, etc.

31
Q

Fill in the blank:
The investigator should report all serious adverse events (SAEs) to the sponsor ________, which the exception of those __________, followed by _______ ________ ________ to the _____ .

A

Immediately
Worth the exception of SAEs stated in the protocol/IB/other documentation that do not need immediate reporting according the the sponsor
Detailed written reports to the sponsor

32
Q

Imagine a clinical trial has been prematurely terminated by the sponsor. What is the responsibility of the investigator and the institution?

A

The investigator needs to inform the institution —> the investigator/institution inform the IRB/IEC and provide them with a detailed written explanation

33
Q

Imagine a clinical trial has been prematurely terminated by the IRB/IEC. What is the responsibility of the investigator? (Per ICH)

A

The investigator must report it to the institution —> investigator/institution inform the sponsor and provide them with a detailed explanation

34
Q

You are a sponsor overseeing a clinical trial, describe the steps to do a Risk Based Quality Management for the trial that adheres to ICH GCP. Provide examples when possible

A
  1. Determine critical processes and identify data that will protect human subjects and ensure reliability
    E.g. randomization, collecting safety information in the form of lab results, vital signs and AES
  2. Risk assessment: determine the risks involved in the processes and data collection methods in the protocol.
    Eg. For system: SOPs not implemented uniformly at different sites
    Eg. For trial: ICF errors, unblinding errors, dose administration errors
  3. Risk evaluation : determine the likelihood of these risks, how likely it is that you will detect them and their impact on patients
  4. Decide which risks to accept or address (depends on the significance and impact of risk)
  5. Risk communication: document all QM activities and communicate with key stake holders on ongoing QM activities and findings
  6. Risk review: review QM activities and make improvements
  7. Risk report: at the end of the trial, create a report summarizing the QM procedures
35
Q

What are the two levels in which risks must be assessed by a sponsor according to ICH GCP?

A

Systematic (EDC, SOPs non compliance) and critical trial specific (e.g. informed consent errors, blinding errors)

36
Q

Whose responsibility is it to ensure Quality Management per ICH GCP?

A

The sponsors

37
Q

Describe Risk Based Quality Management in the context of ICH GCP

A

RB QM is when a Sponsor determined procedures, protocols and processes to protect the safety and privacy of the participants and ensure reliability of the study’s findings.

38
Q

Describe Quality Assurance (QA) and Quality Control (QC) according to ICH GCP? What are examples? Who is responsible for ensuring this?

A

Quality assurance = ACTIONS. The processes, training, SOPs and systems that the study trial implements in order for the study to be conducted and for data to be collected according to the protocol, ICH GCP and applicable regulatory requirements
E.g. SOPs and training for all staff on the protocol, all steps of data handling, etc. Audits and inspections, implementing a data monitoring plan and a data any list/team

Quality Control = VERIFICATION. The operations in place to verify that the study is being conducted and data is being handled per high quality standards in ICG GCP, etc.
E.g. monitoring visits to verify that EMR data was copied accurately to the EDC, programming the EDC to warn/alert of inconsistencies, ranges outside of the norm, etc. Continuous review of data by data analyst/team.

The sponsor

39
Q

Per ICH GCP, should the sponsor be responsible for providing medical advice on trial related questions or problems?

A

No, they should delegate this to a qualified medical profesional or hire an outside consultant

40
Q

In a clinical trial, what is the ultimate responsibility of the sponsor when certain trial-related duties are transferred to a CRO? (Per ICH)

A

The sponsor has full ultimate responsibility of maintaining the integrity, safety and quality of the clinical trial. Even when they choose to delegate some/all of their responsibilities to a CRO.

41
Q

What stakeholders/parties is the Sponsor responsible for including as part of their “team”? (Per ICH)

A
  • Qualified medical professionals to make decisions on trial related questions and issues
  • experts (physicians, biostatisticians, etc) to help with the trial design, data analysis, etc.
  • Management of day-to-day activities by a site manager, CRC, PI, etc
  • They can choose to hire an independent data monitoring committee (IDMC) to inspect the progress of the study trial, assess safety information and endpoints
  • They can choose to hire a CRO to take on some of their responsibilities
42
Q

What is a key responsibility of an independent data-monitoring committee (IDMC) in a clinical trial?

A

An IDMC’s purpose is to assess the progress of the clinical trial and provide guidance on whether it should continue, stop or put on hold. They will assess safety information, efficacy at endpoints, etc.

43
Q

What QA/QC agreements must the sponsor obtain and how must they document it? (Per ICH)

A

The sponsor must obtain written agreements from all of the involved parties in the trial (institution, PI, REB, etc) that data will be accessible and available for any monitoring, auditing and investigations.

44
Q

Provide examples on how the Sponsor can ensure QC is being applied to every stage of the data handling process.

A
  • Monitoring visits where the source documentation (e.g. EMR) is compared to the data entered into the EDC
  • EDC safeguards and alerts for inconsistent data
  • Requirement that data is verified 1-2 times before it is saved
  • IDMC or data analyst/monitoring
45
Q

A trial subject experiences a trial-related injury, and the sponsor is responsible for compensation. What aspect should the sponsor’s policies address in accordance with ICH GCP? (2)

A

The sponsor should provide a treatment and compensation plan (if applicable) for participants that sustain trial related injuries.

The sponsor should provide insurance and/or legal support to the investigator/institution for any claims related to the trial, except for those of malpractice or negligence.

46
Q

A sponsor is planning to initiate a clinical trial. What must they first obtain to comply with ICH GCP before beginning the trial?

A

They must obtain IRB/IEC approval and any other approval from the applicable regulatory requirements before initiating the trial and supplying the IP to the investigator/institution.

47
Q

The sponsor has just selected an investigator for a clinical trial. Before finalizing the agreement, what are the four crucial aspects the sponsor should ensure the investigator agrees to?

A

1) that the investigator/institution will conduct the trial according to ICH GCP, the protocol and aplicable regulatory requirements
2) they will adhere to written procedures about data collection, documentation, recording, etc.
3) they will allow audits, inspections, monitoring visits by applicable agencies
4) they will make Essential Documents available at all times

48
Q

What information must the sponsor obtain about the IRB/IEC, per ICH GCP?

A

1) the name and address of the IRB/IEC
2) a confirmation of approval/favorable opinion from the IRB/IEC about the trial
3) a statement from the IRB/IEC that it is organized and operates according to ICH GCP

49
Q

According to ICG GCP, who is responsible for determining the storage, handling, supply and labelling of an IP?

A

The sponsor

50
Q

What are some aspects of IP handling, supply and documentation that the Sponsor is responsible for in order to adhere to ICH GCP? (5)

A
  • they are responsible for supplying the investigator/institution the IP
  • they are required to determine all handling, storage and disposition parameters/guidances for the IP
  • they need to provide the investigator/institution with written procedures on how to do this at their site
  • they must document all shipping, receiving, disposition activities with the IP
  • must have a system to discard the IP and also recall it if necessary
51
Q

What are the sponsor’s responsibilities regarding the labelling and coding of IPs according to ICH GCP? What must they ensure they have implemented for blinded trials?

A

The sponsor is responsible for creating the labels for the IP and when necessary, coding the IP for blinding purposes.

They must ensure their is a traceable system to determine which IP the participant received in the case of an emergency

52
Q

The sponsor discovers findings that could adversely affect subject safety. What is the sponsor’s responsibility regarding notifying the investigator(s)/institution(s) and regulatory authority(ies) according to ICH GCP?
• A) Notify only if the findings impact the conduct of the trial
• B) Notify after the trial completion
• C) Promptly notify all concerned parties
• D) Notify only if the IRB/IEC requests information

A

C

53
Q

According to ICG GCP, who is responsible for ongoing safety monitoring of the IP?

A

The sponsor

54
Q

What are the purposes of trial monitoring, per ICH GCP?

A
  1. Participants: To ensure the welfare of participants is being protected
  2. Conduct: To ensure the trial is being conducted per the protocol/regulations to ensure integrity of findings
  3. Data: ensure data is accurate, reliable, consistent and complete
55
Q

Per ICH GCP, what considerations must a Sponsor include when determining the extent and nature of monitoring?

A

The sponsor should consider things like study population, complexity, risk, blinding, size, population, etc.

56
Q

What is the preferred method of monitoring per ICH GCP? Are there specific conditions in which one option can solely be used?

A

ICH GCP appears to favour in-person monitoring of trails.

Centralized monitoring is also proposed as an alternative. It seems like studies can implement this as the ONLY option during very special cases and must have strong justifications.

57
Q

A sponsor is exploring monitoring methods and considers centralized monitoring. According to ICH GCP, what is it and what capabilities can centralized monitoring provide? (4)

A

Centralized monitoring is when all of the data from site(s) is evaluated and assessed in one central location. It does not require in person visits to the sites to carry-out monitoring tasks.

Additional functionalities include:
- trends: can evaluate variability and consistency trends
- errors: identify reporting, AE, data entry, outliers, data
- identify sites that may benefit from in-person monitoring
- analyze performance metrics

58
Q

What are the monitors responsibility in assessing investigational product, as outlined in ICH GCP?

A
  • IP accountability (receipt, administration, disposition)
  • IP disposition per protocol/regulatory requirement
  • IP administration and dosing per protocol
  • Storage conditions are compliant and there is enough supply
  • Instructions for participants that need to use, discard, return IP (if applicable)
59
Q

What should be part of a data monitoring plan created by a sponsor, according to ICH GCP. What should the sponsor consider when creating this plan?

A

They should consider the study population, risk and complexity of the study when creating a plan. Things that should be part of it are:
-strategy
- responsibilities of team members in the DMP
- methods and rationale

60
Q

What specific responsibilities does the monitor have in regards to recruitment? (3)

A
  1. IC/EC: Ensure only eligible participants are recruited
  2. IFC: Every participant signs an informed consent form before study activities begin
  3. PI reporting subject recruitment rate
61
Q

Imagine you are a monitor. What aspects of the CRF entries and source documents are you reviewing and evaluating during a site viit, per ICH GCP? (5)

A
  • Ensuring that the data entry and source documentation is complete, accurate, reliable
  • confirming that reports of AES, concurrent medications, current illnesses are being done
  • Withdrawals are properly documented
  • Participant non-compliance in trial components
  • Documenting PDs, or modifications made
62
Q

According to ICH GCP, what are the 9ish unique responsibilities of a monitor?

A
  1. Liaison: facilitating communication between the sponsor and the investigator (including ensuring PI receives most recent versions of IB)
  2. Protocol + agreement adherence: ensuring trail is adhering to protocol, agreements and regulations
  3. CRF and Source Documentation Monitoring
  4. IC/EC: only eligible participants are enrolled
  5. Participants sign an ICF before trial activities start
  6. Ensuring PI is reporting recruitment rate
  7. PI is qualified and has adequate resources to run trial & that the facilities are safely conducting the trial
  8. IP storage, accountability, etc
  9. Reports: providing written, detailed and timely reports to sponsor after each site visit to summarize findings, action items, deviations, etc
63
Q

What is the difference between an audit and an inspection? And who performs each? Which one is part of QA vs QC?

A

An audit is performed by the sponsor. It is part of the Quality Assurance process because it meant to be “preventative” and check that the trial is being conducted appropriately, it is compliant and to identify areas of improvement. Audits are done independent of regulatory inspections.

An inspection is typically done by a regulatory body such as the IRB/IEC,FDA, health canada, etc. The purpose of inspections are to monitor trial activities AND implement corrective actions.

64
Q

What must the Sponsor consider when creating the auditing plan? (4) What should the plan consist of? (4)

A

Sponsors needs to consider:
-complexity of trial
-risks
-participant population and target number
- how important is it for the trial to submit to regulatory organizations

The plan should consist of:
- what to audit
-how
-what is included in the report
-frequency

65
Q

In case of serious noncompliance affecting human subject protection, what does the sponsor need to perform?
• A) Immediate trial suspension.
• B) Root cause analysis and corrective actions.
• C) Rely on investigator’s corrective actions.
• D) Contact the IRB/IEC

A

B

66
Q

What action should the sponsor take if monitoring identifies persistent noncompliance by an investigator?
• A) Increase the frequency of monitoring visits.
• B) Continue monitoring without intervention.
• C) Provide additional funding to the investigator.
• D) Terminate investigator’s participation in the trial.

A

D

67
Q

A clinical trial was prematurely terminated. Who must the sponsor inform, what type of report must they create and who must they submit it?

A

A sponsor has to promptly inform the investigator/institution, the regulatory agencies and the IRB/IEC. They need to provide a reason for the termination/suspension.

They need to create a clinical trial report and submit it to the regulatory agencies as well. This report should comply with the applicable regulatory requirements.

68
Q

What are essential documents? (per ICH GCP)

A

These are clinical trial documents that allow for the proper monitoring and auditing of the trial. (E.g. protocol, IB, etc)

SOCRA Prep 2024 (8 decks)

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