ICH E6 Good Clinical Practice Flashcards
(148 cards)
1
Q
Purpose of GCP
A
Gives standard for designing, conducting, recording, and reporting clinical trials
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
3
Q
IRB primary responsibility
A
Safeguard the rights, safety, and well being of trial subjects
4
Q
IRB provides investigators written what?
A
Approval,
Modifications required to prior approval,
Disapproval,
Termination/suspension of any prior approval
5
Q
IRB conducts _________________ review annually
A
continuing review
-intervals appropriate to degree of risk to human subjects
*but at least one per year
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
7
Q
IRB Composition
A
At least 5 members
-1 primary area is non scientific
-1 independent of trial site
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
9
Q
Investigator promptly reports to IRB (x3)
A
- Deviations from protocol (when necessary to eliminate immediate hazards to subjects)
- Changes increasing risk to subjects or affecting significantly conduct of trial
- ADRs that are serious and unexpected
10
Q
IRB promptly reports what to investigator?
A
- Trial related decisions and opinions
- Reasons for decision
- Procedures to appeal
*all in writing
11
Q
IRB retains records for how long?
A
at least 3 years after completion of trial
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
13
Q
Investigator must allow sponsor and authorities ability to (x3) _____________ clinical trial records
A
to monitor, audit, and inspect
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
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
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
17
Q
At a site, who is Responsible for supervising any individual or party with trial related duties at the site?
A
Principle Investigator
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
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
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
21
Q
Who is responsible for communicating with the IRB?
A
Investigator
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
23
Q
Who provides IRB with updated IB?
A
Investigator
24
Q
Who is responsible for updating the IB
A
The sponsor
25
When is it ok for Investigator to deviate from the protocol?
-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
26
If a protocol deviation occurs, what steps does the investigator take?
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)
27
When the investigator notifies the IRB, sponsor, and regulatory authorities (if required) of a protocol deviation, what should be in this notification?
-Include the implemented deviation or change, the reasons for it, and, if appropriate, the proposed protocol amendment(s)
28
Investigator has what IP responsibilities on site:
-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
29
IP storage and use is determined by who?
Sponsor
30
Investigator has what responsibilities to subject and IP use?
That subject were provided doses specified in protocol, explain correct use of IP to subject, and check if subject is following instructions properly
31
What happens if there is important new information available that may be relevant to the subject’s willingness to continue participation in the trial?
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.
32
Language in the ICF should follow what rules relating to the subject? (two)
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
33
Before informed consent may be obtained the investigator should provide the subject or LAR:
-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
34
The ICF, before subject does any study procedures, should be:
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
35
If subject or LAR is unable to read the ICF:
-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
36
When impartial witness signs the ICF, they are attesting that:
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
37
ICH should contain
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
38
Prior to trial participation, subject should receive (what form):
copy of signed and dated ICF
*signed and dated by subject or LAR and person performing consent
39
If prior consent by subject is not available (emergency situation), what do you do?
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
40
source documents should be (6 things)
Attributable, legible, contemporaneous, original, accurate, and complete
41
who is responsible for maintaining source documents?
Investigator
42
Any change or corrections in CRF should be (4 things)
dated, initialed, and explained, and not obscure original entry
43
Essential documents are retained for how long at site?
- who is responsible for informing when documents are no longer needed?
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
44
Whos informs who when essential documents are no longer needed to be stored?
Sponsor inform investigator
45
Who provides written summaries of trial status to IRB annually?
Investigator
46
Investigator promptly provides written reports to 1)________ and 2)_________on any changes significantly affecting conduct of trial or increasing risks to subjects
1) sponsor
2) IRB
47
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.
1) Sponsor
2) unique code numbers
3) applicable regulatory requirement(s)
48
Investigator reports all unexpected SAES to:
sponsor
*depending on regulatory requirements also to regulatory authorities and IRB
49
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:
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
50
When a study subject dies, the investigator supplies the 1)_________ and 2)__________ with what?
1)sponsor
2)IRB
additional requested info (autopsy, terminal medical reports)
51
If trial is prematurely terminated or suspended for any reason, the investigator should (x3)
1) promptly inform the trial subjects
2) assure appropriate therapy and follow-up for the subjects,
3) inform the regulatory authorities (if required)
52
If investigator terminates or suspends a trial without prior agreement of the sponsor, the investigator should (x3)
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)
53
If the sponsor terminates or suspends a trial the investigator should (x2)
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)
54
If the IRB/IEC terminates or suspends its approval/favorable opinion of a trial the investigator should: (x2)
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)
55
Upon completion of the trial, the investigator should provide final report to: (x2)
1) provide the IRB/IEC summary of the trial’s outcome,
2) regulatory authorities with any report required
56
Who is responsible for study quality management and assurance?
Sponsor
57
Study Quality Management includes:
DELETE
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
58
Who identifies risks to critical trial processes and data?
Sponsor
59
Quality Assurance and Control. What is it, how is it achieved, and who is responsible?
-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
60
What is a CRO
Contract Research Organization
61
Describe sponsor's relationship with a CRO
-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
1)_________ should designate appropriately qualified medical personnel who ill be readily available to advise on trial related medical problems or questions
Sponsor
63
1) Who may consider establish independent data monitoring committee (DMC)?
2) What is a DMC function?
1) Sponsor
2) assess progress of trial including: safety data, critical endpoints, recommend to sponsor to continue, modify, or stop trial
64
Original trial data should be ___________ with processed data?
possible to compare the original data
65
Subject's should be identified by
An unambiguous subject identification code
66
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)
1) Sponsor
2) completeness, accuracy, reliability, and consistent intended
performance (i.e. validation)
*should have audit trail
67
If trial is discontinued, what should the sponsor do with essential documents?
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
If sponsor discontinues trial, they should inform
investigator and regulatory authorities
69
Who is responsible for selecting investigator for trials
the sponsor
70
Before entering agreement with investigator, sponsor should:
- Provide protocol, IB, and sufficient time for review
71
The sponsor should obtain the investigator agreement to:
1) conduct the trial in:
2) follow what document?
3) permit what?
4) retain what?
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
What is indemnification? What does it not protect from?
Sponsor provided insurance/legal/financial coverage against claims arising from trial
DOES NOT protect against malpractice or negilgence
73
The sponsor's policies and procedures should address the costs of treatment of trial subjects in the ___________________________
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
The financial aspects of the trial should be ________________in an agreement between the sponsor and the investigator/institution.
documented
75
Before _______________, the sponsor (or sponsor and investigator) should submit any required application to regulatory authority for review, acceptance, and permission to begin the trial
initiating trial
*submission should be dated and contain sufficient information to ID protocol
76
The sponsor obtains from the investigator what information about the IRB? (x3)
-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
Who updates IB with significant new info as it becomes available?
Sponsor
78
Name sponsor responsibilities with IP: (x3)
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
In blinded trials, the coding system should include a mechanism that ______________
permits rapid ID of product in case of medical emergency, but does not permit undetectable breaks in blinding
80
Who supplies IP for the study?
Sponsor
81
Sponsor IP supplying and handling responsibilities: (x5)
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
Sponsor should not supply IP to site until:
obtains all required documentation (e.g., approval/favourable opinion from IRB/IEC and regulatory authority(ies)
83
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
investigator and subject
84
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
1) Sponsor
2) serious and unexpected
85
The ____________is responsible for the ongoing safety evaluation of the investigational product(s).
Sponsor
86
The sponsor should submit to the____________ all safety updates and periodic reports, as required
regulatory authority(ies)
87
The sponsor should promptly notify (who) __________ and ________ of findings that could affect _________________
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
3 Main purposes of monitoring
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
Monitors are appointed by the (who)___________
Sponsor
90
Qualifications of Monitor (x2)
- 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
__________ ensures trials are adequately monitored and determine appropriate extent and nature of monitoring
Sponsor
*not determined by regulatory requirement but by Sponsor SOPs
92
What is central monitoring?
remote evaluation of accumulating data performed in timely manner by data managers or biostatisticians
93
Who is main communication between sponsor and site?
Monitor
94
A monitors primary responsibilities (x2) are?
-Ensure trial is conducted and documented property
-Protection of subject
95
Who reports subject recruitment rate?
The monitor
96
The monitor ___________ the trial is conducted and documented properly
verifies
97
What is a CRF?
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
Monitor CRF responsibilities:
Checks the accuracy and completeness of the CRF entries, source documents and other trial-related records against each other
99
If the monitor finds any CRF error, omission, or illegibility they should:
-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
The monitor should submit a written report to the 1)_________ after each 2)___________ or ___________
Reports should include:
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
Purpose of Audit
Reason for audit
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
What determines audit procedures, scope, and frequency?
Who appoints auditors?
Sponsor written SOPs
Sponsor, should be independent of clinical trial system
103
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?
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
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 _________
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
Premature Termination or Suspension of Trial by sponsor, what happens?
Sponsor promptly informs investigator and regulatory authorities of termination and reason
*investigator promptly informs IRB
106
Define Clinical Trial Report
written description of trial in human subjects in which clinical and statistical description, presentations, and analyses are fully integrated in a single report
107
Who prepares clinical trial reports?
Who do they give them to?
The sponsor
regulatory agency
108
Study Protocol shound include:
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
1) What is the IB?
2) What does in provide investigators with (generally)?
3) info in IB should be
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
1)__________ is responsible for ensuring up to date IRB made available to investigators
2)__________ is responsible for providing up to date IB to IRBs
1) The Sponsor
2) the investigator
111
IB should include
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
IB Summary
1) provides investigator with?
2) IB information based on?
3) Gives guidance on?
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
Essential Document, define
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
_________ should have control of all essential documents and records generated by investigator before, during, and after trial
Investigator
*sponsor should not have exclusive control of CRF data
115
Essential Document Location (Investigator or Sponsor)
ADVERTISEMENT FOR SUBJECT RECRUITMENT
Investigator
116
Essential Document Location (Investigator or Sponsor)
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE COMPOSITION
Investigator
117
Essential Document Location (Investigator or Sponsor)
MEDICAL/LABORATORY/TECHNICAL PROCEDURES /TESTS
Sponsor
118
Essential Document Location (Investigator or Sponsor)
SAMPLE OF LABEL(S) ATTACHED TO INVESTIGATIONAL PRODUCT
CONTAINER(S)
Sponsor
119
Essential Document Location (Investigator or Sponsor)
CERTIFICATE(S) OF ANALYSIS OF INVESTIGATIONAL PRODUCT(S) SHIPPED
Sponsor
120
Essential Document Location (Investigator or Sponsor)
DECODING PROCEDURES FOR BLINDED TRIALS
Investigator
121
Essential Document Location (Investigator or Sponsor)
MASTER RANDOMISATION LIST
Sponsor
122
Essential Document Location (Investigator or Sponsor)
PRE-TRIAL MONITORING REPORT
Sponsor
123
Essential Document Location (Investigator or Sponsor)
REGULATORY AUTHORITIES AUTHORISATIONS/APPROVALS/NOTIFICATIONS WHERE REQUIRED for protocol amendments
Sponsor
124
Essential Document Location (Investigator or Sponsor)
UPDATES OF MEDICAL/LABORATORY/TECHNICAL PROCEDURES/TESTS
Sponsor
125
Essential Document Location (Investigator or Sponsor)
CERTIFICATE(S) OF ANALYSIS FOR NEW BATCHES OF INVESTIGATIONAL PRODUCTS
Sponsor
126
Essential Document Location (Investigator or Sponsor)
MONITORING VISIT REPORTS
Sponsor
127
Essential Document Location (Investigator or Sponsor)
SIGNED INFORMED CONSENT FORMS
Investigator
128
Essential Document Location (Investigator or Sponsor)
SOURCE DOCUMENTS
Investigator
129
Essential Document Location (Investigator or Sponsor)
SIGNED, DATED AND COMPLETED CASE REPORT FORMS (CRF)
Investigator original
Sponsor copy
130
Essential Document Location (Investigator or Sponsor)
DOCUMENTATION OF CRF CORRECTIONS
Investigator original
Sponsor copy
131
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
Sponsor
132
Essential Document Location (Investigator or Sponsor)
INTERIM OR ANNUAL REPORTS TO IRB/IEC AND AUTHORITY(IES)
Investigator
133
Essential Document Location (Investigator or Sponsor)
SUBJECT SCREENING LOG
Investigator
134
Essential Document Location (Investigator or Sponsor)
SUBJECT IDENTIFICATION CODE LIST
Investigator
135
Essential Document Location (Investigator or Sponsor)
SUBJECT ENROLMENT LOG
Investigator
136
Essential Document Location (Investigator or Sponsor)
DOCUMENTATION OF INVESTIGATIONAL PRODUCT DESTRUCTION
Investigator (if destroyed on site)
Sponsor
137
Essential Document Location (Investigator or Sponsor)
COMPLETED SUBJECT IDENTIFICATION CODE LIST
Investigator
138
Essential Document Location (Investigator or Sponsor)
AUDIT CERTIFICATE
Sponsor
139
Essential Document Location (Investigator or Sponsor)
FINAL TRIAL CLOSE-OUT MONITORING REPORT
Sponsor
140
Essential Document Location (Investigator or Sponsor)
TREATMENT ALLOCATION AND DECODING DOCUMENTATION
Sponsor
141
Essential Document Location (Investigator or Sponsor)
FINAL REPORT BY INVESTIGATOR TO IRB/IEC WHERE REQUIRED, AND WHERE APPLICABLE, TO THE REGULATORY AUTHORITY(IES)
Investigator
142
Essential Document Location (Investigator or Sponsor)
CLINICAL STUDY REPORT
Sponsor
143
What is the ICH?
International Council for Harmonisation.
144
What does the ICH Harmonized Guideline for Good Clinical Practiced describe?
The responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs.
145
IRB Requirements
- 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
(For Investigator) All SAES are to be reported (how quickly) to (who)?
immediately to sponsor and IRB (per regulatory guidelines)
147
Study data transcription errors can be corrected by the monitor (T/F)
True
148
What occurs at the pre-study visit?
Sponsor evaluates the investigator and staff qualifications as well as adequacy of facilities and resources
