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Investigator/Sponsor/Monitor Responsibilities Flashcards

1
Q

Select qualified investigators and monitors

A

GCP: Sponsor Responsibilities (IND/IDE)

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2
Q

Provide information needed to conduct the investigation properly

A

GCP: Sponsor Responsibilities (IND/IDE)

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3
Q

Ensure Proper Monitoring, IRB Review and Approval

A

GCP: Sponsor Responsibilities (IND/IDE)

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4
Q

Ensure investigation conducted in accordance with the general investigational plan and protocols contained in the IND/IDE; maintain effective IND/IDE

A

GCP: Sponsor Responsibilities (IND/IDE)

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5
Q

Ensure FDA and all participating investigators are promptly informed on significant new adverse effects or risks with respect to the investigational product

A

GCP: Sponsor Responsibilities (IND/IDE)

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6
Q

Obtain agreement from the investigator/institution for adherence to the protocol, to obtain IRB approval, and GCP compliance

A

GCP: Sponsor Responsibilities (IND/IDE)

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7
Q

Notify all involved parties, if warranted, of new safety information adversely affecting subject safety or IRB favorable opinion

A

GCP: Sponsor Responsibilities (IND/IDE)

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8
Q

Secure Compliance

A

GCP: Sponsor Responsibilities (IND/IDE)

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9
Q

Obtain Signed 1572 (pharmaceutical investigation) or Investigator Agreement (device investigation) which includes:
-CV
-Statement of Investigator’s relevant experience
-Explanation of termination circumstances
-Statement of investigator commitment

A

GCP: Sponsor Responsibilities (21 CFR 312/21 CFR 812)

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10
Q

Maintain quality assurance and quality control systems with written SOPs for all activities

A

GCP: Sponsor Responsibilities

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11
Q

Provide medical expertise (might be a consultant)

A

GCP: Sponsor Responsibilities

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12
Q

Studies designed by qualified individuals (physicians, statistician, other clinical scientists)

A

GCP: Sponsor Responsibilities

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13
Q

May transfer any or all of their responsibilities to a contract research organization (CRO)
-Transferred responsibilities must be described in writing

A

GCP: Sponsor Responsibilities

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14
Q

Ensure Proper Monitoring - through developing monitoring plans that manage important risks to human subjects and data quality and address the challenges of oversight in part by taking advantage of the innovations in modern clinical trials

A

GCP: Sponsor Responsibilities

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15
Q

Manufacturing, packaging, labeling, and coding of the investigational product

A

GCP: Sponsor Responsibilities

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16
Q

Providing the investigational product only to investigators participating in an investigation

A

GCP: Sponsor Responsibilities

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17
Q

Maintain drug and device accountability records from manufacturing through use, return and destruction

A

GCP: Sponsor Responsibilities

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18
Q

Promptly report information about significant new adverse events, new information or risks with respect to the investigational product or investigations to FDA and investigators

A

GCP: Sponsor Responsibilities

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19
Q

If it’s determined that the IP (Investigational Product) presents an unreasonable an significant risk to study subjects, the __________ must:

-Discontinue all studies that present the risk
-Notify FDA, all investigators involved in the study(ies) and their IRBs
-Assure return and accounting for all investigational product, its return or on-site destruction

A

Sponsor

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20
Q

Submit Safety Reports (Expedited Reporting), if appropriate

A

GCP: Sponsor Responsibilities

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21
Q

Provide pre-clinical and clinical study reports in information amendments to the IND/IDE

A

GCP: Sponsor Responsibilities

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22
Q

Submit and annual report to the IND/IDE

A

GCP: Sponsor Responsibilities

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23
Q

Required to obtain clinical investigator financial information before allowing the clinical investigator to participate in a covered clinical study (marketing application)

A

GCP: Sponsor Responsibilities - Financial Disclosure (21CFR54)

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24
Q

FDA Form 3454

A

Certification: Financial Interests and Arrangements of Clinical Investigators (no disclosable financial interest in or arrangements with the sponsor of the covered clinical study)

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25
FDA Form 3455
Disclosure: Financial Interests and Arrangements of Clinical Investigators (individual has participated in financial arrangements or holds financial interests that require to be disclosed)
26
Promptly secure compliance, or discontinue shipments of the investigational product to the investigator and terminate the investigator's participation in the investigation
GCP: Sponsor Responsibilities
27
Requires the investigator to dispose of or return investigational product, unless this action would jeopardize the rights, safety, or welfare of a subject
GCP: Sponsor Responsibilities
28
Verify the rights and well-being of human subjects are protected
GCP: Monitor (CRA) Responsibilities
29
Verify that reported trial data are accurate, complete, and verifiable from source documents
GCP: Monitor Responsibilities
30
Ensure the study is conducted in compliance with the study protocol, the GCP guidelines, and applicable regulations
GCP: Monitor Responsibilities
31
The monitor is appointed by the ________.
Sponsor
32
_________ should be appropriately trained and have the scientific and/or clinical knowledge needed to monitor the trial adequately
Monitors
33
________ should be thoroughly familiar with the investigational product, protocol, consent and other written study material
Monitors
34
_______ act as the main line of communication between the sponsor and the investigator
Monitors
35
Verifies: -Investigator qualifications -Appropriate product storage, handling, and accountability -Investigator compliance with the protocol, regulations, and GCP guidelines
Monitor
36
Perform site initiation visit to include PI and study team (IRB not required)
Monitor
37
Complete written reports regarding each visit
Monitor (CRA)
38
Ensures review and follow-up by the sponsor on corrective actions are documented
Monitor (CRA)
39
Identifies missing data, inconsistent data, data outliers, unexpected lack of variability and protocol deviations
Monitor (CRA) - ICH E6(R2)
40
Examines data trends such as the range, consistency, and variability of data within and across sites
Monitor (CRA) - ICH E6(R2)
41
Evaluates for systematic or significant errors in data collection and reporting at a site or across sites; or potential data manipulation or data integrity problems
Monitor (CRA) - ICH E6(R2)
42
Analyze site characteristics and performance metrics
Monitor (CRA) - ICH E6(R2)
43
Select sites and/or processes for targeted on-site monitoring
Monitor (CRA) - ICH E6(R2)
44
FDA Form 1572
Statement of Investigator (Investigator Responsibilities)
45
Confirms reading and understanding information in the investigator's brochure, including potential risks and side effects of the drug
GCP: Investigator Responsibilities
46
Will personally conduct or supervise the investigation
GCP: Investigator Responsibilities
47
Agrees to ensure all associates, colleagues, and employees assisting with the conduct of the study are informed of their obligations, such as transcribing data from the source document to the CRF.
GCP: Investigator Responsibilities
48
Has adequate time and resources to conduct the study properly
GCP: Investigator Responsibilities
49
Ensures IRB approval is obtained prior to starting any study related activities.
GCP: Investigator Responsibilities (FDA 1572 Form)
50
Ensures that an IRB complies with requirements of 21 CFR 56 will be responsible for initial and continuing review
GCP: Investigator Responsibilities (FDA 1572 Form)
51
Promptly reports to the IRB all changes in the research activity and unanticipated problems
GCP: Investigator Responsibilities (FDA 1572 Form)
52
Agrees to not make any changes in the research without sponsor and IRB approval, except to eliminate immediate hazards to human subjects
GCP: Investigator Responsibilities (FDA 1572 Form)
53
Conducts the study in accordance with the relevant, current protocol
GCP: Investigator Responsibilities (FDA 1572 Form)
54
Obtain informed consent from each subject before entry into the study (before any study related procedures)
GCP: Investigator Responsibilities
55
Explain the proper use of the investigational product to subjects
GCP: Investigator Responsibilities
56
Ensure proper storage and handling of study drug/device; accountability, return or destruction of unused study drug
GCP: Investigator Responsibilities
57
Ensure investigational product is used only by individuals who have agreed to participate in clinical trials as evidenced by signed written informed consent
GCP: Investigator Responsibilities
58
Assure investigational product is used only by the investigator or qualified subinvestigators
GCP: Investigator Responsibilities
59
Assure provision of medical care be given to study patients for study related adverse events
GCP: Investigator Responsibilities
60
Report adverse events during the study (21 CFR 312.64)
GCP: Investigator Responsibilities
61
Maintain adequate and accurate records (21 CFR 312.62) and make study records available for inspection (21 CFR 312.68) (ALCOA-C)
GCP: Investigator Responsibilities
62
Verify via Accountability Records: -Doses specified in protocol were provided to subjects -Drug/device was provided only to study subjects -Use by study subjects reconciles the amounts received and returned to the sponsor -Product was stored as specified by the sponsor and in compliance with applicable regulations -Device was used for its intended purpose
GCP: Investigator Responsibilities
63
Annual of more frequent written summaries to the IRB/IEC as required by the IRB/IEC
GCP: Investigator Responsibilities
64
Safety reporting - serious and other adverse events, abnormal laboratory values, etc
GCP: Investigator Responsibilities
65
Responsible for final written summary to the IRB/IEC
Investigator
66
21 CFR Part 11
Electronic Records; Electronic Signatures
67
21 CFR Part 50
Protection of Human Subjects
68
21 CFR Part 54
Financial Disclosure by Clinical Investigators
69
21 CFR Part 56
Institutional Review Boards
70
21 CFR Part 312
Investigational New Drug Application
71
21 CFR Part 812
Investigational Device Exemptions
72
FDA Form 3500
Voluntary safety reporting
73
FDA Form 3500A
Mandatory safety reporting
74
FDA Form 1571
Investigational New Drug Application (IND)
75
FDA Form 482
Notice of Inspection - notice that FDA will visit facility
76
FDA Form 483
Notice of Inspectional Observations - form listing the FDA's findings from inspection

SOCRA CCRP (1 decks)

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