GCP 4. INVESTIGATOR
(T/F) If treatment is deemed medically urgent, the investigator and/or designated member of the trial staff can exert pressure on a subject to continue.
FALSE No coercion or undue influence should ever be used. 4.8.3
(T/F) Only the ICF can contain language causing the subject or his/her representative to waive or appear to waive legal rights or release or appear to release the investigator, sponsor or agents from negligence claims.
FALSE No communication, oral or written, can release the investigator, sponsor, or agents from claims oF negligence.
(T/F) A signed ICF releases the investigator from liability for negligence.
FALSE No oral or written communication can release the investigator , institution, sponsor, or appointed agents from liability for negligence. 4.8.4
(T/F)As long as an investigator has an experienced research coordinator, the investigator does not need to be totally familiar with regulatory requirements.
FALSE The investigator should be aware of and comply with GCPs and applicable regulatory requirements. 4.1.3
(T/F) As long as the investigator provides the IRB/IEC with the original IB required for review, the investigator need not submit minor updates.
FALSE The investigator/ institution must provide the IRB/IEC with all updates to the IB, as well as all other documents that are subject to its review. 4.4.2
(T/F) The investigator/institution is only responsible for informing a subject of the need and providing medical care to remedy an AE during the course of the trial.
FALSE The responsibility continues during a subject's participation in a trial and following any intercurrent illness(es) of which the investigator is aware. 4.3.2
(T/F)The monitor is responsible for ensuring that individuals assisting with the trial are adequately informed of the protocol, IP, and duties of the assistance?
FALSE This is the responsibility of the Investigator. 4.2.4
(T/F) Investigators must reconcile and document all investigation supplies received from the sponsor, but need not document the subjects received appropriate doses in accordance with the protocol.
False Investigator must also document that subject received appropriate doses. 4.6.3
How is a non-therapeutic trial distinct from a therapeutic trial and how does this affect sampling?
A non-therapeutic trial is one in which there is no anticipated direct clinical benefit to the subject. In these trials consent is even more important. 4.8.13
With what documents must the CRF be consistent?
The CRF must be consistent with the source documents; if there are discrepancies , these must be explained. 4.9.2
Who is accountable for IP at the trial site?
The Investigator/institution is accountable and when allowable or appropriate should designate responsibility to an appropriate pharmacist or another individual who is under its supervision. 4.6.1
What types of information must be provided to the IRB/IEC and sponsor in the case of reported deaths?
Autopsy reports and terminal medical reports are examples of the types of information that is required. 4.11.2
What method should be used for breaking a blind code and whom must be the investigator notify?
The blind should be broken only in accordance with the protocol and the investigator must notify the sponsor promptly, providing details of the unblinding. 4.7
What types of changes to protocols must the IRB/IEC be notified of and in what must be explained in the notification?
~ ANY changes made to the protocol ~The written documentation must explain the reason for the change 4.5.3
When non-therapeutic trials involve subjects who are unable to personally grant consent, what extra steps must be taken?
~The IP should be intended for the subject's disease or condition and ~subjects must be closely monitored and withdraw if they become unduly distressed. 4.8.14
Who must sign the written ICF prior to a subject's participation in a trial?
~subject or subject's legally acceptable representative as well as the ~person who conducted the IC discussion must sign and date the form. 4.8.8
Under what conditions can subjects who cannot personally grant consent participate in non-therapeutic trials?
Second-party consent is acceptable if: ~Objectives cannot otherwise be met ~Risks to subjects are low ~Negative impact on subject well-being are low ~The trial is not prohibited by law ~IRB/IEC approval was obtained 4.8.14
What is meant by the phrase "adequate resources" in relation to study conduct?
"adequate resources" means having: ~a potential to recruit a sufficient sample population in the agreed recruitment period, ~enough qualified staff members, ~adequate facilities and ~enough time to properly conduct and complete the study. 4.2
Who must maintain trial documents and what regulation apply to the maintenance of trail documents?
-The investigator/institution must maintain the documents. -Documents must be maintained in accordance with: ~Essential Documents for the Conduct of a Clinical Trial and ~any applicable regulatory requirements. 4.9.4
Who makes trial-related medical decisions?
A qualified physician who is an investigator or subinvestigator is responsible for these decisions. 4.3.1
How much information must be given to a potential subject or the subject's legally acceptable representative?
All available information as well as responses to questions posed by the individual or his/her representative and an impartial witness, if applicable, should be answered fully in non-technical terms. 4.8.5
If a potential subject or a legally acceptable representative is unable to read, how is consent obtained?
An impartial witness must be present for the discussions and must witness the signing and dating of the subject or subject's representative. 4.8.9
What document includes stipulations pertaining to situations in which neither the subject nor the subject's representative can grant consent?
Conditions which neither the subject/representative can grant consent must be specified in: ~protocol or ~supporting documents approved by the IRB/IEC 4.8.15
From whom must the investigator receive approval before issuing a revised ICF?
Consent must be received from: -the IRB/IEC. -Subject or subject's legally acceptable representative should be informed of any new information that might affect the subject's willingness to continue to participate. 4.8.2
How does an investigator demonstrate the potential for recruiting the required number of suitable subjects within the agreed recruitment period?
Demonstration is based on retrospective data. 4.2.1
Which documents can exempt certain SAEs from requirement of immediate reporting to the sponsor?
Documents can exempt certain SAEs from requirement of immediate reporting to the sponsor are: ~Protocol or ~IB 4.11.1
For how long must essential documents be retained?
Essential documents should be retained for: ~at least two years after the last marketing application approval in an ICH region and until there are no pending/contemplated marketing application in the region OR ~two years after formal discontinuation of clinical development of the product. 4.9.5
What constitutes evidence of an investigator's qualifications to conduct a trial?
Evidence of qualifications includes up-to-date CV and/or other relevant documentation requested by the sponsor, IRB/IEC or the regulatory authority(ies) 4.1.1
(T/F) The investigator inform the subject's primary physician of the subject's participation in the study.
FALE The investigator must have subject's consent before informing the primary physician. 4.3.3
Subjects are fully obligated to give their reason for prematurely discontinuing a trail since the reason may affect the overall reporting and outcomes of the trial.
FALSE A subject is not obliged to give the reason for early discontinuation, but the investigator should attempt to ascertain it, making sure to respect the subject's rights. 4.3.4
IC must make the potential subject aware of what monetary considerations?
IC must make subjects aware of compensation, prorated payments, anticipated expenses, compensation for injury, and terms of withdrawal. 4.8.10
IC must make the potential subject aware of what confidentiality considerations?
IC must make the potential subject aware of: ~the right to refuse to participate or to withdraw without loss of other benefits ~the sponsor, IRB/IEC, regulatory and investigator's staff will have access to the medical records ~the data will be confidential ~the contracts for information or for injury will be provided ~any new information will be provided 4.8.10
What procedures must be followed if data recorded on a CRF is modified?
If data recorded on a CRF is modified, the change must be: ~dated, ~initialed and explained, if required; ~the original data must still be viewable. 4.9.3
How does the investigator/ institution confirm acceptance of the terms of the protocol and any other relevant regulatory requirements?
Indicates confirmation by signing the protocol or an alternative contract. 4.5.1
How must investigators store investigational supplies?
Investigational supplies must be stored in accordance with applicable regulatory and sponsor requirements. 4.6.4
When must the investigator submit written summaries of the trial's status of the institution?
Investigator must submit written summaries of the trial's status of the institution when: ~required by the applicable regulatory requirements. 4.10.1
With what documents should the investigator be familiar to ensure appropriate use of the IP?
Investigator should be thoroughly familiar with the -Protocol -current IB -product information and -any other information provided by the sponsor. 4.1.2
For what items must the investigator/ institution have written approval/favorable opinion from an IRB/IEC prior to initiating a trial?
Investigator/institution must have: ~Written ICFs ~Subject recruitment procedures ~Supplemental subject information 4.4.1
Informed consent must make the potential subject aware of what medical considerations?
It must reveal the research ~nature of the trial, ~its purpose, ~its benefits/risks, ~the probability of random treatment assignments, ~use of invasive procedures ~alternative treatments, ~subject's responsibilities, and ~experiment ail aspects of the trial. 4.8.10
If an unauthorized change to a protocol is made, the investigator must document the change and notify who?
Must request IRB/IEC review, inform the sponsor, and (if required) the regulatory authority. 4.5.4
What steps must be taken when dealing with population that include subjects who require consent form a legally acceptable authority (e.g., minors)?
Populations of subjects who require consent form a legally acceptable authority should be informed about: ~the trial to the extent compatible with his/her understanding and, ~when possible, be asked to sign and date the written ICF 4.8.12
What is the minimum time frame in which the investigator/institution must submit written trial progress reports to the IRB/IECs?
Reports must be submitted annually, or more frequently if the IRB/IEC requests. 4.10.1
To whom must AEs and/or laboratory abnormalities identified in the protocol as critical to safety evaluation be reported?
Such events should be reported to the sponsor according to the reporting requirements for the protocol. 4.11.2
How many investigational supplies can be used by an investigator?
Supplies can only be used in accordance with the terms of the approved protocol. 4.6.5
(T/F) The investigator/ institution must allow the sponsor to monitor and appropriate regulatory authority(ies) to audit the study.
TRUE 4.1.4
(T/F) In addition to supplying the IRB/IEC with summaries of the trial's outcome, the investigator/institution should also file reports with the sponsor and with the regulatory authority(ies), if required.
TRUE 4.13
(T/F) Investigators/institutions or their designee should ensure that all research subjects receive an explanation of proper use of the test medication and that their use is correct at appropriate intervals throughout the study.
TRUE 4.6.6
(T/F) Potential subjects must be informed of the approximate length of the trial and the number of subjects involved in the trial as well as foreseeable circumstances for termination of the subjects participation.
TRUE 4.8.10
(T/F) The ICH/GCP Guidelines requires a written financial agreement between the sponsor and investigator/institution.
TRUE 4.9.6
Who is responsible for the accuracy, completeness, legibility, and timeliness of data reported to the sponsor?
The investigator is responsible for all data in the CRFs and other required reports. 4.9.1
Regardless of who terminates or suspends a trial, who must provide a detailed written explanation of the termination or suspension?
The investigator is responsible for informing all affected parities (e.g., the sponsor and the IRB/IEC). 4.13
When obtaining consent from a subject, an investigator should comply with applicable regulatory documents and what two other governing principles?
The investigator must adhere to both ~GCPs ~ethical principles(w/origin in the Declaration of Helsinki) 4.8.1
Who maintains the list of qualified people assigned significant trial-related duties? (SSRS log)
The investigator must maintain this list. 4.1.5
What must an investigator do after reporting a SAE to the sponsor?
The investigator must provide a detailed, written report. 4.11.1
Who must retain records of changes and corrections made to the CRF?
The investigator must retain records of changes and corrections made to the CRF. 4.9.3
To whom must the investigator report unexpected SAE drug reactions?
The investigator should notify the regulatory authority(ies) and the IRB/IEC, as mandated with applicable regulatory requirements. 4.11.1
To whom should written reports be submitted if there are any changes that significantly affect the conduct of the trial and/or increase the risk to subjects?
The investigator should promptly notify ~the sponsor, ~the IRB/IEC, and ~where required by regulatory requirements, the institution. 4.10.2
What information must be provided to a subject prior of the beginning of the trial?
The investigator should provide subjects with the IRB/IEC's written approval/ favorable opinion of the ~written ICF and ~any other written information that is pertinent to participation. 4.8.2
What qualifies an investigator to conduct a study?
The investigator's qualifications included education training and experience as well as familiarity with the appropriate use of the IP. 4.1.1
Who has authority to prematurely suspend or terminate a trial?
The investigator, the institution, the sponsor, or the IRB/IEC can suspend or terminate a study prematurely. 4.12
What reports must the investigator/institution provide to the IRB/IEC following completion of a trial?
The investigator/institution must provide the IRB/IEC with a summary of the trial's outcome. 4.13
What actions must the investigator or institution take if a study is terminated prematurely or suspended prior to completion?
The investigator/institution should promptly inform all subjects, make arrangements for appropriate therapy and follow-up activities, and inform regulatory authorities, if applicable. 4.12
Who may request access to trial-related documents?
The monitor, auditor, IRB/IEC, or regulatory authority may make such a request. 4.9.7
Records of product delivery, inventory, subject usage, return and/or other disposition of IP must include what information?
The records should include ~dates, ~quantities, ~batch/serial number, ~expiration dates, if applicable, and ~the unique code numbers 4.6.3
Who is responsible for determining when documents no longer needed to be maintained?
The sponsor is responsible for informing the investigator/institution of when documents can be discarded. 4.9.5
How much time must the subject or the subjects legal representative be provided prior to signing an ICF?
The subject/representative must be given ample time to review the details and ask questions about the trial. 4.8.7
What document must the subject, or the subjects legally acceptable representative, receive prior to participation in the trial?
The subject/representative should receive a copy of the ~signed and dated written ICF and ~any other written information provided to the subjects. ~Updates should be provided during the duration of the trial. 4.8.11
How are subjects identified when SAEs are reported?
The unique code number assigned as part of the preliminary trial enrollment identifies subjects. 4.11.1
When should the written ICF be updated?
The written ICF should be updated: -whenever important new information becomes available that might be relevant to a subject's consent. 4.8.2
What must the investigator/institution prevent from happening to the trial documents?
They must prevent accidental or premature destruction of these documents. 4.9.4
Under what conditions may an investigator amend the protocol without receiving prior approval from the sponsor and IRB/IEC?
Unauthorized amendments can be made to eliminate an immediate hazard to trial subjects or when changes are logistical/administrative in nature. 4.5.2
What must the sponsor do to ensure that CRF corrections are made correctly?
To ensure that CRF corrections are made correctly the sponsor should have written procedures that ensure: ~that changes are necessary, ~they are endorsed by the investigator, and that ~they are documented. 4.9.3