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ACRP - CCRC Exam > ICH E6 Good Clinical Practice > Flashcards

ICH E6 Good Clinical Practice Flashcards

1
Q

Purpose of GCP

A

Gives standard for designing, conducting, recording, and reporting clinical trials

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2
Q

What does GCP provide (3 things)

A
  • provides public assurance that rights, safety, and well-being of trial subjects are protected and consistent with principles in Declaration of Helsinki
    -provide unified standard for different regulatory authorities
    – facilitate mutual acceptance of clinical data
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3
Q

IRB primary responsibility

A

Safeguard the rights, safety, and well being of trial subjects

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4
Q

IRB provides investigators written what?

A

Approval,
Modifications required to prior approval,
Disapproval,
Termination/suspension of any prior approval

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5
Q

IRB conducts _________________ review annually

A

continuing review
-intervals appropriate to degree of risk to human subjects
*but at least one per year

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6
Q

Describe how GCP standards for subject payment (x3)

A

-amount and method of payment that doesn’t present coercion or undue influence
-Should be prorated and not contingent on completion of trial
-Payment information written in ICF

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7
Q

IRB Composition

A

At least 5 members
-1 primary area is non scientific
-1 independent of trial site

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8
Q

1) IRB requirements for making decisions (x2)
2) IRB SOPs, decision, and composition must be in what form?

A

1) Make decisions at ANNOUNCED meetings that has QUORUM (majority)
2) Written

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9
Q

Investigator promptly reports to IRB (x3)

A
  1. Deviations from protocol (when necessary to eliminate immediate hazards to subjects)
  2. Changes increasing risk to subjects or affecting significantly conduct of trial
  3. ADRs that are serious and unexpected
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10
Q

IRB promptly reports what to investigator?

A
  1. Trial related decisions and opinions
  2. Reasons for decision
  3. Procedures to appeal
    *all in writing
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11
Q

IRB retains records for how long?

A

at least 3 years after completion of trial

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12
Q

Investigator is
1) Qualified by:

2) Shows qualifications by:

3) Must be familiar with:

A

1) education, training, and experience and meet all regulatory requirements

2) Up to date CV

3) Proper use of IP, protocol, IB, and be aware and comply with GCP and regulatory requirements

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13
Q

Investigator must allow sponsor and authorities ability to (x3) _____________ clinical trial records

A

to monitor, audit, and inspect

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14
Q

No deviations of protocol should be initiated without 1)____________.

2) Exception

A

1) Prior written approval from the IRB

2) when necessary to eliminate immediate hazards to subjects or change involving logistical or administerial aspects

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15
Q

What is the delegation of duty log? And who keeps it?

A

List of appropriately qualified persons to whom the investigator has delegated significant trial related duties (DoD Log)

Maintained by investigator

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16
Q

Investigator must demonstrate adequate resources for trial, name these resources

A

a. Demonstrate potential for recruiting required number of subjects within recruiting period
b. Have sufficient time to properly conduct and complete trial
c. Have adequate number of qualified staff and facilities for foreseen duration of trial
d. Ensure all persons assisting in trial are adequately trained on protocol, IP, an trial related duties

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17
Q

At a site, who is Responsible for supervising any individual or party with trial related duties at the site?

A

Principle Investigator

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18
Q

Who is responsible for all trial related medical decisions?

A

A qualified physician, who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical (or dental) decisions

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19
Q

Should subject’s primary physician be informed of trial participation?

A

Recommended that investigator informs subjects primary physician about the subjects participation in trial IF SUBJECT AGREES

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20
Q

What happens if subject withdraws from study?

A

Investigator makes reasonable effort to ascertain the reason why subject withdraws from trial
*not required by subject to give reason

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21
Q

Who is responsible for communicating with the IRB?

A

Investigator

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22
Q

What is needed from IRB before enrolling a subject?

A

written and dated approval from IRB regarding:
-protocol, ICFs, subject recruitment procedures, and any other written information provided to subjects

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23
Q

Who provides IRB with updated IB?

A

Investigator

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24
Q

Who is responsible for updating the IB

A

The sponsor

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25
Q

When is it ok for Investigator to deviate from the protocol?

A

-Agreement by sponsor and prior approval from IRB
-EXCEPT when necessary to eliminate an immediate hazard to subjects of when changes involves logistical or administrative aspects of trial (change in monitor, change in phone number

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26
Q

If a protocol deviation occurs, what steps does the investigator take?

A

ASAP notify
a) the IRB/IEC for review and approval/favorable opinion,
b) to the sponsor for agreement
c) to the regulatory authorities (if required)

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27
Q

When the investigator notifies the IRB, sponsor, and regulatory authorities (if required) of a protocol deviation, what should be in this notification?

A

-Include the implemented deviation or change, the reasons for it, and, if appropriate, the proposed protocol amendment(s)

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28
Q

Investigator has what IP responsibilities on site:

A

-Maintain records of product delivery, inventory on site, use by subject, return and destruction records, IP stored properly on site
-reconcile all IP received from sponsor
-train subject on proper use and make sure they are using it correctly

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29
Q

IP storage and use is determined by who?

A

Sponsor

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30
Q

Investigator has what responsibilities to subject and IP use?

A

That subject were provided doses specified in protocol, explain correct use of IP to subject, and check if subject is following instructions properly

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31
Q

What happens if there is important new information available that may be relevant to the subject’s willingness to continue participation in the trial?

A

1) revise ICF
2) the revised ICF should receive IRB/IEC’s approval/favorable opinion in advance of giving to the subject
3) The subject or LAR should be informed in a timely manner
4) revised ICF must be signed before continuing research
*communication of this information should be documented.

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32
Q

Language in the ICF should follow what rules relating to the subject? (two)

A

1) should not cause subject to waive any legal rights, or releases or appear to release investigator, institution, sponsor, or agents of liability for negligence
2) non-technical as practical and should be understandable

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33
Q

Before informed consent may be obtained the investigator should provide the subject or LAR:

A

-ample time and opportunity to inquire about details of the trial and to decide whether or not to participate in the trial.
-All questions about the trial should be answered to the satisfaction of the subject or the subject’s

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34
Q

The ICF, before subject does any study procedures, should be:

A

signed and personally dated by subject/LAR and person who conducted ICF discussion BEFORE ANY STUDY PARTICIPATION OCCURS
*Prior to participation in the trial the subject or LAR should receive a copy of the signed and dated written informed consent form

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35
Q

If subject or LAR is unable to read the ICF:

A

-an impartial witness should be present during the entire informed consent discussion.
-AFTER subject/LAR orally consents and, if able, signs/dates ICF impartial witness should sign and personally date ICF

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36
Q

When impartial witness signs the ICF, they are attesting that:

A

the information in the consent form accurately explained to, and
apparently understood by, the subject or LAR, and that
informed consent was freely given by the subject or LAR

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37
Q

ICH should contain

A

i. Trial is research
ii. Purpose
iii. Treatment and probability for random assignment
iv. Trial procedures
v. Subjects responsibilities
vi. Aspects of trial that are experimental
vii. Reasonably foreseeable risks
viii. Reasonably expected benefits
ix. Alternative treatments
x. Compensations/treatment available in event of trial related injury
xi. Anticipated payment
xii. Anticipated expenses
xiii. Subject participant is voluntary
xiv. Monitor, auditor, IRB, and regulatory authored who will be granted direct access to subjects medical records to verify trial procedures and data – and the subject is authorizing this access
xv. Records identifying subject are confidential
xvi. Subject will be informed in a timely manner if info becomes available that may be relevant to subjects willingness to continue trial
xvii. Person to contact for further info regarding trial and rights of subjects, and whom to contact for trial related injury
xviii. Foreseeable circumstances and reasons which trial may be terminated
xix. Expected duration of subjects participation in trial
xx. Approximated number of subjects in trial

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38
Q

Prior to trial participation, subject should receive (what form):

A

copy of signed and dated ICF
*signed and dated by subject or LAR and person performing consent

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39
Q

If prior consent by subject is not available (emergency situation), what do you do?

A

1) LAR consent
2) If LAR not available - require measures described in IRB approved protocol
3) The subject or LAR should be informed about the trial as soon as possible and CONSENT TO CONTINUE in study

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40
Q

source documents should be (6 things)

A

Attributable, legible, contemporaneous, original, accurate, and complete

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41
Q

who is responsible for maintaining source documents?

A

Investigator

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42
Q

Any change or corrections in CRF should be (4 things)

A

dated, initialed, and explained, and not obscure original entry

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43
Q

Essential documents are retained for how long at site?

  • who is responsible for informing when documents are no longer needed?
A

2 years after last approval of marketing application
Or at least 2 years since formal d/c of clinical development of IP

*Can be retained for longer if required by regulatory authorities or by agreement with sponsor

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44
Q

Whos informs who when essential documents are no longer needed to be stored?

A

Sponsor inform investigator

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45
Q

Who provides written summaries of trial status to IRB annually?

A

Investigator

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46
Q

Investigator promptly provides written reports to 1)________ and 2)_________on any changes significantly affecting conduct of trial or increasing risks to subjects

A

1) sponsor
2) IRB

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47
Q

All unexpected serious adverse events (SAEs) should be reported immediately to the 1) ____________

These reports should identify subjects by 2) __________ assigned to the trial subjects rather than by the subjects’ names, personal identification numbers, and/or addresses.

The investigator should also comply with the 3)___________related to the reporting of unexpected serious adverse drug reactions to the regulatory authority(ies) and the IRB/IEC.

A

1) Sponsor

2) unique code numbers

3) applicable regulatory requirement(s)

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48
Q

Investigator reports all unexpected SAES to:

A

sponsor
*depending on regulatory requirements also to regulatory authorities and IRB

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49
Q

ADR reporting

1) Investigators report to the sponsor

2) Sponsors report to regulatory authorties: 

3) Sponsors should also inform investigators:

4) Investigators and sponsors report to the IRB:

A

1) All ADRs

2) Any ADRs that are both serious and unexpected

3) Any new observations regarding the drug, especially AEs and safe use concerns

4) All unanticipated SAEs

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50
Q

When a study subject dies, the investigator supplies the 1)_________ and 2)__________ with what?

A

1)sponsor
2)IRB

additional requested info (autopsy, terminal medical reports)

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51
Q

If trial is prematurely terminated or suspended for any reason, the investigator should (x3)

A

1) promptly inform the trial subjects
2) assure appropriate therapy and follow-up for the subjects,
3) inform the regulatory authorities (if required)

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52
Q

If investigator terminates or suspends a trial without prior agreement of the sponsor, the investigator should (x3)

A

1) should promptly inform the sponsor
2) should promptly inform the IRB/IEC,
3) provide the sponsor and the IRB/IEC a detailed written explanation of the termination or suspension

*also per GCP 4.12.1 promptly inform the trial subjects, assure appropriate therapy and follow-up for the subjects, and inform the regulatory authorities (if required)

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53
Q

If the sponsor terminates or suspends a trial the investigator should (x2)

A

1) promptly inform the IRB/IEC
2)provide the IRB/IEC a detailed written explanation of the termination or suspension.

*also per GCP 4.12.1 promptly inform the trial subjects, assure appropriate therapy and follow-up for the subjects, and inform the regulatory authorities (if required)

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54
Q

If the IRB/IEC terminates or suspends its approval/favorable opinion of a trial the investigator should: (x2)

A

1) should promptly notify the sponsor
2) provide the sponsor with a detailed written explanation of the
termination or suspension

*also per GCP 4.12.1 promptly inform the trial subjects, assure appropriate therapy and follow-up for the subjects, and inform the regulatory authorities (if required)

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55
Q

Upon completion of the trial, the investigator should provide final report to: (x2)

A

1) provide the IRB/IEC summary of the trial’s outcome,
2) regulatory authorities with any report required

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56
Q

Who is responsible for study quality management and assurance?

A

Sponsor

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57
Q

Study Quality Management includes:

DELETE

A

The design of efficient clinical trial protocols and tools and procedures for data collection and processing and collection of info essential to decision making

Ensure all aspects of trial are operationally and unnecessarily complex

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58
Q

Who identifies risks to critical trial processes and data?

A

Sponsor

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59
Q

Quality Assurance and Control. What is it, how is it achieved, and who is responsible?

A

-systematic process used to determine if research is accurate and complete and the results are consistent with established protocol and procedures
- achieved by implementing and maintaining quality assurance control systems with written SOPs
-sponsor

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60
Q

What is a CRO

A

Contract Research Organization

61
Q

Describe sponsor’s relationship with a CRO

A

-Sponsor may transfer any or all trial related duties to CRO but sponsor is still ultimate responsibility for quality and integrity of trial data
- Should be specified in writing
-Any trial related duties not specifically transferred are retained by sponsor

62
Q

1)_________ should designate appropriately qualified medical personnel who ill be readily available to advise on trial related medical problems or questions

A

Sponsor

63
Q

1) Who may consider establish independent data monitoring committee (DMC)?
2) What is a DMC function?

A

1) Sponsor

2) assess progress of trial including: safety data, critical endpoints, recommend to sponsor to continue, modify, or stop trial

64
Q

Original trial data should be ___________ with processed data?

A

possible to compare the original data

65
Q

Subject’s should be identified by

A

An unambiguous subject identification code

66
Q

1) Who is responsible for setting up electronic trial data handling and/or remote electronic trial data systems
2) Requirements of the electronic trial data system (x4)

A

1) Sponsor
2) completeness, accuracy, reliability, and consistent intended
performance (i.e. validation)
*should have audit trail

67
Q

If trial is discontinued, what should the sponsor do with essential documents?

A

Maintain all essential documents at least 2 years after formal D/C or conformance with regulatory requirements
*Sponsor notify all trial investigators and all reg. authorities for records retention and notify in writing when trial related records are no longer needed

68
Q

If sponsor discontinues trial, they should inform

A

investigator and regulatory authorities

69
Q

Who is responsible for selecting investigator for trials

A

the sponsor

70
Q

Before entering agreement with investigator, sponsor should:

A
  • Provide protocol, IB, and sufficient time for review
71
Q

The sponsor should obtain the investigator agreement to:
1) conduct the trial in:
2) follow what document?
3) permit what?
4) retain what?

A

1) In compliance with GCP under regulatory requirements,
2) follow IRB approved protocol
3) Permit monitoring, auditing, and inspection
4) Retain trial related essential documents until the sponsor informs the investigator these documents are no longer needed
*Sponsor and investigator should sign the protocol or alt. document to confirm this

72
Q

What is indemnification? What does it not protect from?

A

Sponsor provided insurance/legal/financial coverage against claims arising from trial

DOES NOT protect against malpractice or negilgence

73
Q

The sponsor’s policies and procedures should address the costs of treatment of trial subjects in the ___________________________

A

event of trial-related injuries in accordance with the applicable regulatory requirement
*trial subjects receive compensation, the method and manner of compensation should comply with applicable regulatory requirement

74
Q

The financial aspects of the trial should be ________________in an agreement between the sponsor and the investigator/institution.

A

documented

75
Q

Before _______________, the sponsor (or sponsor and investigator) should submit any required application to regulatory authority for review, acceptance, and permission to begin the trial

A

initiating trial
*submission should be dated and contain sufficient information to ID protocol

76
Q

The sponsor obtains from the investigator what information about the IRB? (x3)

A

-The name and address of the IRB
-A statement obtained from the IRB/IEC that it is organized and operates according to GCP and the applicable laws and regulations.
-documentation and dates of IRB continuing reviews, withdrawal or suspensions of approval

77
Q

Who updates IB with significant new info as it becomes available?

A

Sponsor

78
Q

Name sponsor responsibilities with IP: (x3)

A

1) manufactured in accordance with GMP
2)coded and labelled in manner that protects blinding but also rapid ID of product in case of medical emergency
3)acceptable storage temps, storage conditions, storage times, reconstitution processes, and devices for product infusion

79
Q

In blinded trials, the coding system should include a mechanism that ______________

A

permits rapid ID of product in case of medical emergency, but does not permit undetectable breaks in blinding

80
Q

Who supplies IP for the study?

A

Sponsor

81
Q

Sponsor IP supplying and handling responsibilities: (x5)

A

i. Timely delivery
ii. Maintain records that document shipment, receipt, disposition, returns, and destruction of IP
iii. Maintain system for retrieving IP and documenting retrieval (recall, after trial completion, expired product)
iv. Maintain system for disposition of unused IP and documentation of disposition
v. Ensures that SOPs include instructions that site should follow for handling and storage and documentation of IP, and return / destruction

82
Q

Sponsor should not supply IP to site until:

A

obtains all required documentation (e.g., approval/favourable opinion from IRB/IEC and regulatory authority(ies)

83
Q

Sponsor should verify that __________________ and ___________________has agreed to in writing, to direct access to
source data/original medical records for trial-related monitoring, audit, IRB/IEC review, and regulatory inspection

A

investigator and subject

84
Q

Adverse Drug Reaction Reporting

1) Who should expedite reporting to all investigators, regulatory authorities, and IRB (where required)

2) Adverse events must be both _________ and ________ for expedited reporting

A

1) Sponsor
2) serious and unexpected

85
Q

The ____________is responsible for the ongoing safety evaluation of the investigational product(s).

A

Sponsor

86
Q

The sponsor should submit to the____________ all safety updates and periodic reports, as required

A

regulatory authority(ies)

87
Q

The sponsor should promptly notify (who) __________ and ________ of findings that could affect _________________

A

investigator(s)/institution(s) regulatory authority(ies)

affect adversely the safety of subjects, impact the conduct of the trial, or alter the IRB/IEC’s approval/favorable opinion to continue the trial.

88
Q

3 Main purposes of monitoring

A

i. Protect rights and well being of subjects
ii. Data are accurate, complete, and verifiable from source documents
iii. Conduct of trial in compliance with GCP an regulatory requirements

89
Q

Monitors are appointed by the (who)___________

A

Sponsor

90
Q

Qualifications of Monitor (x2)

A
  • appropriate trained
    -have scientific and clinical knowledge
    -thoroughly familiar with IP, protocol, ICF, written info given to subjects, sponsor SOP, GCP, and reg. requirements
    *all this should be documented
91
Q

__________ ensures trials are adequately monitored and determine appropriate extent and nature of monitoring

A

Sponsor
*not determined by regulatory requirement but by Sponsor SOPs

92
Q

What is central monitoring?

A

remote evaluation of accumulating data performed in timely manner by data managers or biostatisticians

93
Q

Who is main communication between sponsor and site?

A

Monitor

94
Q

A monitors primary responsibilities (x2) are?

A

-Ensure trial is conducted and documented property
-Protection of subject

95
Q

Who reports subject recruitment rate?

A

The monitor

96
Q

The monitor ___________ the trial is conducted and documented properly

A

verifies

97
Q

What is a CRF?

A

Case Report Form:

a paper or electronic questionnaire specifically used in clinical trial research. The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient

98
Q

Monitor CRF responsibilities:

A

Checks the accuracy and completeness of the CRF entries, source documents and other trial-related records against each other

99
Q

If the monitor finds any CRF error, omission, or illegibility they should:

A

-ensure that appropriate corrections, additions, or deletions are made
-The corrections are explained (if necessary), and initialed by the by a member of the investigator’s trial staff who is authorized

100
Q

The monitor should submit a written report to the 1)_________ after each 2)___________ or ___________

Reports should include:

A

1) Sponsor
2) trial-site visit or trial-related communication.

-summary of what the monitor reviewed
-the monitor’s statements concerning the significant findings/facts, deviations and deficiencies, conclusions, actions taken or to be taken and/or actions recommended to secure compliance.

101
Q

Purpose of Audit

Reason for audit

A

evaluate trial conduct and compliance with the protocol, SOPs,
GCP, and the applicable regulatory requirements

middle of a study, database lock or right at the end of enrollment, site is a high enroller or has had numerous problems with resolving compliance issues.

102
Q

What determines audit procedures, scope, and frequency?

Who appoints auditors?

A

Sponsor written SOPs

Sponsor, should be independent of clinical trial system

103
Q

1) Sponsor audits are dependent or independent from monitoring?

2) Are audits apart of quality assurance or control ?

3) Should regulatory authorities request audit reports?

A

1) Independent and separate from monitoring or quality control

2) quality assurance

3) To preserve independence and value of audit – regulatory authorities should NOT routinely request audit reports
*May request when evidence of serious GCP non compliance exists or course of legal proceedings

104
Q

Noncompliance
1) If occurs, should trigger _____________ to secure compliance

2) If significantly affects or has potential to affect subject protection or data reliability

3) If monitoring or audit IDs serious or persistent noncompliance of investigator should________, then notify _________

A

1) prompt action by sponsor

2) sponsor perform root cause analysis and implement appropriate corrective and preventive actions

3) sponsor should terminate investigator participation in trial
Sponsor promptly notify reg. authorities

105
Q

Premature Termination or Suspension of Trial by sponsor, what happens?

A

Sponsor promptly informs investigator and regulatory authorities of termination and reason
*investigator promptly informs IRB

106
Q

Define Clinical Trial Report

A

written description of trial in human subjects in which clinical and statistical description, presentations, and analyses are fully integrated in a single report

107
Q

Who prepares clinical trial reports?

Who do they give them to?

A

The sponsor

regulatory agency

108
Q

Study Protocol shound include:

A

i. General Info (protocol title, amendment, name and address of sponsor, sponsor info and contact info, etc)
ii. Background info (name and description of IP, summary of findings on IP, risks, description and justification of IP dose and route, statement trial conduced in compliance of GCP and reg. requirements, population to be studied
iii. Trial objects and Purpose
iv. Trial Design
1. Primary/secondary endpoints, type of trial, measurements to minimize bias (randomization and blinding), etc
v. Selection Withdrawal of Subjects
vi. Treatment of Subjects
vii. Assessment of Efficacy
viii. Assessment of Safety
ix. Statistics
x. Direct Access of Source Data
xi. Quality Control and Assurance
xii. Ethics
xiii. Data Handling and Record Keeping
xiv. Financing and Insurance
xv. Publication Policy
xvi. Supplements

109
Q

1) What is the IB?
2) What does in provide investigators with (generally)?
3) info in IB should be

A
  1. Compilation of clinical and nonclinical data of IP that are relevant to the study of product in human subjects
  2. Provides investigators with info to facilitate understanding and rationale for compliance with protocol (IP dosing and AEs)
  3. info should be concise, simple, objective, balances, and non promotional that enables doctor to understand and make his own unbiased risk benefit assessment of appropriateness of proposed trial
110
Q

1)__________ is responsible for ensuring up to date IRB made available to investigators

2)__________ is responsible for providing up to date IB to IRBs

A

1) The Sponsor

2) the investigator

111
Q

IB should include

A

a. Title Page (sponsor name, ID of IP, generic name, research number)
b. Confidentiality Statement
c. Tables of Contents
d. Summary
e. Intro
f. Physical, Chemical, and Pharm. Properties and Formulation
g. Non Clinical Studies
h. Non clinical Pharm
i. Pharm. Kinetics and Product Metabolism in Animals
j. Toxicology
k. Effect in Humans

112
Q

IB Summary
1) provides investigator with?
2) IB information based on?
3) Gives guidance on?

A

1) provides investigator with clear understanding of possible risks and AEs, and of specific tests, observations, and precautions needed for trial.
2) on physical, chemical, pharmaceutical, pharmacological, toxicology, and clinical info on IP
3) recognition and treatment of possible overdose and ADRs based on previous experience

113
Q

Essential Document, define

A

documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced
*demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all
applicable regulatory requirement
*are documents found in investigator site files and subject binders, basically all trial related documents

114
Q

_________ should have control of all essential documents and records generated by investigator before, during, and after trial

A

Investigator
*sponsor should not have exclusive control of CRF data

115
Q

Essential Document Location (Investigator or Sponsor)

ADVERTISEMENT FOR SUBJECT RECRUITMENT

A

Investigator

116
Q

Essential Document Location (Investigator or Sponsor)

INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE COMPOSITION

A

Investigator

117
Q

Essential Document Location (Investigator or Sponsor)

MEDICAL/LABORATORY/TECHNICAL PROCEDURES /TESTS

A

Sponsor

118
Q

Essential Document Location (Investigator or Sponsor)

SAMPLE OF LABEL(S) ATTACHED TO INVESTIGATIONAL PRODUCT
CONTAINER(S)

A

Sponsor

119
Q

Essential Document Location (Investigator or Sponsor)

CERTIFICATE(S) OF ANALYSIS OF INVESTIGATIONAL PRODUCT(S) SHIPPED

A

Sponsor

120
Q

Essential Document Location (Investigator or Sponsor)

DECODING PROCEDURES FOR BLINDED TRIALS

A

Investigator

121
Q

Essential Document Location (Investigator or Sponsor)

MASTER RANDOMISATION LIST

A

Sponsor

122
Q

Essential Document Location (Investigator or Sponsor)

PRE-TRIAL MONITORING REPORT

A

Sponsor

123
Q

Essential Document Location (Investigator or Sponsor)

REGULATORY AUTHORITIES AUTHORISATIONS/APPROVALS/NOTIFICATIONS WHERE REQUIRED for protocol amendments

A

Sponsor

124
Q

Essential Document Location (Investigator or Sponsor)

UPDATES OF MEDICAL/LABORATORY/TECHNICAL PROCEDURES/TESTS

A

Sponsor

125
Q

Essential Document Location (Investigator or Sponsor)

CERTIFICATE(S) OF ANALYSIS FOR NEW BATCHES OF INVESTIGATIONAL PRODUCTS

A

Sponsor

126
Q

Essential Document Location (Investigator or Sponsor)

MONITORING VISIT REPORTS

A

Sponsor

127
Q

Essential Document Location (Investigator or Sponsor)

SIGNED INFORMED CONSENT FORMS

A

Investigator

128
Q

Essential Document Location (Investigator or Sponsor)

SOURCE DOCUMENTS

A

Investigator

129
Q

Essential Document Location (Investigator or Sponsor)

SIGNED, DATED AND COMPLETED CASE REPORT FORMS (CRF)

A

Investigator original
Sponsor copy

130
Q

Essential Document Location (Investigator or Sponsor)

DOCUMENTATION OF CRF CORRECTIONS

A

Investigator original
Sponsor copy

131
Q

Essential Document Location (Investigator or Sponsor)

NOTIFICATION BY SPONSOR AND/OR INVESTIGATOR, WHERE APPLICABLE, TO REGULATORY AUTHORITY(IES) AND
IRB(S)/IEC(S) OF UNEXPECTED SERIOUS ADVERSE DRUG REACTIONS AND OF OTHER SAFETY INFORMATION

A

Sponsor

132
Q

Essential Document Location (Investigator or Sponsor)

INTERIM OR ANNUAL REPORTS TO IRB/IEC AND AUTHORITY(IES)

A

Investigator

133
Q

Essential Document Location (Investigator or Sponsor)

SUBJECT SCREENING LOG

A

Investigator

134
Q

Essential Document Location (Investigator or Sponsor)

SUBJECT IDENTIFICATION CODE LIST

A

Investigator

135
Q

Essential Document Location (Investigator or Sponsor)

SUBJECT ENROLMENT LOG

A

Investigator

136
Q

Essential Document Location (Investigator or Sponsor)

DOCUMENTATION OF INVESTIGATIONAL PRODUCT DESTRUCTION

A

Investigator (if destroyed on site)

Sponsor

137
Q

Essential Document Location (Investigator or Sponsor)

COMPLETED SUBJECT IDENTIFICATION CODE LIST

A

Investigator

138
Q

Essential Document Location (Investigator or Sponsor)

AUDIT CERTIFICATE

A

Sponsor

139
Q

Essential Document Location (Investigator or Sponsor)

FINAL TRIAL CLOSE-OUT MONITORING REPORT

A

Sponsor

140
Q

Essential Document Location (Investigator or Sponsor)

TREATMENT ALLOCATION AND DECODING DOCUMENTATION

A

Sponsor

141
Q

Essential Document Location (Investigator or Sponsor)

FINAL REPORT BY INVESTIGATOR TO IRB/IEC WHERE REQUIRED, AND WHERE APPLICABLE, TO THE REGULATORY AUTHORITY(IES)

A

Investigator

142
Q

Essential Document Location (Investigator or Sponsor)

CLINICAL STUDY REPORT

A

Sponsor

143
Q

What is the ICH?

A

International Council for Harmonisation.

144
Q

What does the ICH Harmonized Guideline for Good Clinical Practiced describe?

A

The responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs.

145
Q

IRB Requirements

A
  • 5 members of varying backgrounds including 1 community member
  • Must meet at least annually
  • Must have a quorum present
  • Decisions must be in writing
146
Q

(For Investigator) All SAES are to be reported (how quickly) to (who)?

A

immediately to sponsor and IRB (per regulatory guidelines)

147
Q

Study data transcription errors can be corrected by the monitor (T/F)

A

True

148
Q

What occurs at the pre-study visit?

A

Sponsor evaluates the investigator and staff qualifications as well as adequacy of facilities and resources

ACRP - CCRC Exam (14 decks)

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