Investigator roles/responsibilities Flashcards
Required qualifications of the clinical investigator
-qualified by education, training, and exp per regulations
-familiar with intervention
-allows sponsor to monitor and audit
Trial-related medical/dental decisions should be made by:
qualified physician/dentist who is PI or SUB-I
Who is responsible for documenting/explaining any deviation from the protocol?
The investigator or person designated by PI
What is required for an Investigator to implement a deviation from the protocol?
-Approval of change from sponsor and IRB/IEC
-If immediate hazard to trial subjects is possible or the change is logistical/administrative, approval is NOT required.
Investigator implements a deviation from the protocol to eliminate hazard to subject w/o approval, what must happen next?
-ASAP: indicate reasons for change and if needed, proposed protocol changes should be submitted to
1) IRB/IEC for review
2) Sponsor for agreement
3) Regulatory bodies (only if req)
Investigational products should be stored as specified by the ___:
Sponsor
What records should be maintained for an investigational product?
1) Delivery of the product to site
2) Product inventory
3) Use of what product by each subject
4) Return/disposition of unused product at study termination
5) IDs, dates, quantities, S/N, and etc
If the trial is blinded, the ___ should promptly document and explain to the ___ any premature unblinding of the investigational products.
Investigator, Sponsor
When should be an ICF be revised?
When new information that is pertinent to subject’s consent and will require IRB/IEC approval prior to use.
ICF should be signed AND personally dated by the ___ (or ____ if applicable) and the ___.
Subject (LAR), and the person who conducted consent discussion
What if the subject or LAR is unable to read?
An impartial witness needs to be present during the entire discussion to attest to the consent as it was orally presented. Both subject/LAR witness must sign/date ICF.
According to ICH GCP, which of the following is NOT included in consent discussion?
1) That the trial involves research
2) Probability for random assignment
3) Trial procedures to be followed
4) Sponsor of the trial
5) The investigator’s CV
6) Subject responsibilities
5
According to ICH GCP, which of the follow is NOT included in consent discussion?
1) Foreseeable risks
2) Possible benefits
3) Name of the IRB/IEC for approval
4) Alternative procedures/course of treatment and its corresponding risk/benefits
5) Demographic of patient population previously tested
6) Possible compensation/treatment who sustain trial-related injury
3 & 5
According to ICH GCP, which of the follow is NOT included in consent discussion?
1) Other interventions the sponsor is developing
2) Anticipated expenses
3) Monitor/auditor, IRB/IEC, and regulatory bodies will be granted access to their medical records, confidentially.
4) Records are confidential
5) Point of contact for study info
6) Subject will be informed ASAP regarding any new information that is pertinent to their participation
1
According to ICH GCP, which of the follow is NOT included in consent discussion?
1) Foreseeable situations where subject’s participation is terminated
2) Duration of participation
3) Number of patients for study objective
4) Software for data analysis
5) Possible payments
6) Contacts for regulatory bodies
4
What is considered a SERIOUS AE or SERIOUS ADR?
Any untoward medical occurrence that:
-Results in death
-Is life threatening
-Requires hospitalization and extension of hospitalization
-Disability
-Birth defect
What is an UNEXPECTED ADR?
An adverse reaction in which the nature/severity is not consistent with the initially presented investigator brochure/consent.
What is an AE?
Any untoward medical occurrence. Does not need to be causal with study treatment. (i.e. unintended symptom and/or lab findings).
What is ADR?
All noxious and unintended responses to a study drug. Requires a reasonable causality between the reaction/study drug.
How long should essential documents be retained following marketing approval/termination of the study?
2 years
For an IND, what FDA form is filled out by the investigator as an agreement between the sponsor and investigator to perform the trial accordingly?
Form 1572 (Statement of the Investigator)
Which FDA forms allows investigators to disclose financial interests? What form if there are NO financial interests they need to disclose?
Form 3455 & Form 3454
How often should investigator submit summaries of trial status to the IRB/IEC?
At least annually, or per IRB/IEC requirements.
For serious expected AEs, who should the investigator report to and when?
SAE need to be reported to sponsor ASAP, detailed written reports should be submitted following the initial report.
If investigator terminates/suspends an active trial w/o prior agreement from sponsor, who should the investigator reach out to?
If sponsor terminates a trial, who should they reach out to?
If IRB/IEC terminates a trial, who should they reach out to?
Sponsor and IRB/IEC with written explanation.
Sponsor informs investigator, who in turns informs IRB/IEC
IRB/IEC informs investigator, who in turns informs the sponsor.
What is a priority for investigators to complete following study completion?
investigator should provide IRB/IEC and relevant regulatory bodies with a final report.
What is an Independent Data Monitoring Committee (IDMC)?
Established by SPONSOR to assess study progress (consents and etc) at regular intervals to assure subject safety and ascertain efficacy endpoints in order to inform sponsor if a study should continued, be modified, or be terminated.
What is a monitoring report?
Report written by monitor to the sponsor after a site visit or trial-related communication.
ALCOA-C
Attributable
Legible
Contemporaneous
Original
Accurate
Complete
Stronger together
Whom are generally considered vulnerable populations?
Individuals whose willingness to volunteer may be higher secondary to the expected benefits from the participation OR perceived RETALIATION of not participating
Investigators must conduct their study per protocol and other regulations with utmost priority of what:
protection of rights, safety, and welfare of subjects (form 1572)
Investigators must maintain “Disposition of Drug”
Maintain records of disposition of drug including dates, quantity, and use by subjects. Unused supplies return to sponsor
Investigators must maintain “Case Histories”
Establish record of all consents, observations, and data pertinent to each subject per CRF and SOP guidelines.
How long must investigators maintain record retention?
2 years of record retention following the data marketing application is approved, or pretty much as laid out in the contractual obligation by sponsor
Who is responsible for ensuring that the study is conducted in compliance with protocol and regulatory requirements?
The Principal Investigator (PI) has ultimate responsibility for ensuring the study’s compliance with the protocol and regulations. Sponsor shares this role and is considered to be their “main purpose.”
