Clinical Trial Activities 2 Flashcards
When can the enrolment of subjects begin?
They must receive approval from EC (ethics committee) /IRB approval (institutional review board) and after site initiation
Who carries out the subject recruitment?
PI (principle investigator), Co-Investigator
The clinical investigator has primary responsibility of recruiting subjects, ensuring that only eligible subjects are enrolled in the study and obtaining and documenting the informed consent of each subject
What does the CRC do in terms of Informed Consent for the paitent?
They explain the IC and documenting process, they DO NOT sign the ICF the clinical investigator is in charge of that
Who revises the I/E ?
IRB institutional review board/ HSA (singapore)
How do we check the eligibility of the subjects? How do we define the study population?
using the I/E criteria, the patient must not meet any exclusion criteria
Criteria for clinical trial eligibility defining the study population by:
1. Defining diseases
- Excluding subjects likely to suffer from adverse effects from the experimental therapy and attempting to ensure the outcome can be measured
- Determining who is the population that the potential study patients will be selected from
What is the significance of the inclusion/ exclusion criteria? How does it affect the study?
Eligibility criteria must be carefully reviewed at the planning stage
Once trial is initiated they must be strictly adhered to
The stricter the I/E criteria, the smaller the study population
Enrolment of ineligible subjects interferes with the credibility of the results
leads to invalid results- patient dropout
What are the 3 conditions to be satisfied when we consider an informed consent process is properly conducted?
- decision is voluntary (not influenced by anyone or convinced/ no persuasion)
- an appropriate understanding of the circumstances (they must comprehend the circumstances)
- patient’s choice is deliberate; patient has carefully considered all of the expected benefits, burdens, risks, adverse events and reasonable alternatives
Define investigational product (IP):
“study drug”
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use
-in other words
Pharmaceutical form of an active ingredient or placebo/ drug used as a reference in a clinical trial
includes a product with a marketing authorization when used or assembled in a different way from the approved form or use for an unapproved indication, or when used to gain further information about an unapproved use
How are Investigational Products handled?
Quality of the investigational product is assured by compliance with Good Manufacturing Practice (GMP) and by handling and storing the product according to the manufacturing specifications and the study protocol
Who controls the access to the IP, within GCP?
GCP requires that sponsors control access to the investigational product :
- control access
- quantity produced
- whom product is shipped
- disposition of unused supplies
What is included in the study records?
Study records documenting each trial-related activity provide critical verification that the study has been carried out in compliance with the protocol
How should research be conducted?
Research should be conducted according to the approved protocol and applicable regulatory requirements
Safety management, Who is responsible for alerting the sponsor and the IEC/IRB to adverse events?
The clinical investigator has primary responsibility for alerting the sponsor and IEC/IRB to adverse events, particularly serious/life-threatening unanticipated events, observed during the course of the research
CRC also supports this role however Clinical Investigator has the primary responsibility
Site response report includes:
-treat all AE (adverse event)/ SAE (serious adverse event) until resolution
Who should you report to in the event of SAE (serious adverse event)?
Sponsor
IRB (institutional review board)
SAE (serious adverse event) referring to an adverse event not listed in the IB (investigator brochure)
What is the role of the sponsor once they have been alerted of an SAE (serious adverse event)?
The sponsor, in turn has primary responsibility for reporting of study safety to regulatory authorities and other investigators ongoing global safety assessment of the investigational product
A data and safety monitoring board (DSMB) may be constituted by the sponsor to assist in overall safety management (they may terminate the study/ continue/ change study design
What is the definition of study monitoring?
The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded and reported in accordance with the protocol, (SOP) standard operating procedure, (GCP) good clinical practice and the applicable regulatory requirements
Who carries out study monitoring?
Sponsor CRA (clinical research associate)
CRO (clinical research organization) CRA (clinical research associate),
Sponsors generally perform site monitoring of a clinical trial to assure high quality trial conduct every 4-6 weeks
Extent and nature of monitoring, What does the Sponsor, CRA, CRO check when monitoring?
Ensures the trials are adequately monitored
Determines the appropriate extent (referring to the frequency of the visits) and nature (referring to type such as on-site or remote monitoring) of monitoring
What factors increases the frequency visits/ monitoring?
The more complex a study is
The larger patient size
The more end point that we collect
Increases the frequency of the monitoring
What is the purpose of trial monitoring?
The purpose of trial monitoring are to verify that:
- the rights and well-being of human subjects are protected (ICF obtain)
- the reported trial data are accurate, complete and verifiable from source documents (medical documents) (AE/SAE)
- the conduct of the trial is in compliance with the currently approved protocol/ amendments(s) , with GCP and with the applicable regulatory requirements
What does the Investigator control when it comes to handling the IP? within GCP
Control the receipt, administration (contains dosing record, accountability record, dispose/return) and disposition of the investigational product
What is the qualification of a monitor (CRA)?
Should be appropriately trained, and should have the scientific and/or clinical knowledge needed to monitor the trial adequately
His/her qualification should be documented
A monitor should be thoroughly familiar with..
- the investigational product(s)
- the protocol
- written informed consent form
- any other written information to be provided to subjects
- the sponsor’s SOP
- GCP trained
- the applicable regulatory requirements
