Clinical trials Activities 1 Flashcards
Protocol definition:
A document that describes the objective(s), design, methodology, statistical, considerations and organization of a trial
- objectives
- designs
- methodology (single blind, double blind methods)
- statistical (sample numbers)
- considerations
- organization of a trial
What does ICH mean?
International Conference of Harmonization
Development of Protocol, who develops protocol in Clinical Trials and what does it include?
Within GCP, clinical trials should be described in a clear, detailed protocol
The sponsor, often in consultation with 1 or more clinical investigators, generally designs the study protocols
Clinical Investigators may be in house investigators or done through collaboration with hospitals
What is I/E criteria?
I/E stands for inclusion/ exclusion criteria used to define the eligibility of the patient
-check if the patients meet all the inclusion criteria
Definition of SOPs:
Standard operating Procedure
Who is responsible for providing the support systems and tools?
Sponsor is responsible for developing, maintaining, modifying and ensuring the availability of support systems and tools for conducting the trial and collecting and reporting required data
Examples of trial information documents:
- Investigator’s brochure (contains the expected adverse effects, everything about the IP, pre clinical studies information, toxicity, PK/PD
- Checklists to identify and document the required steps for each of the various clinical trial activities (e.g investigator selection, approvals and clearances, monitoring, adverse event reporting and evaluation)
- Investigational supplies accountability forms to document the amount and source of investigational product shipped and received, and the return/destruction, as appropriate, of any unused product
- Signature logs (state responsibility and initial for the study team) and other forms to document by whom activities are completed, when, and the sequence in which they are carried out
- Case report forms for each scheduled study visit to capture all of the necessary data collected from and reported for each subject
- Informed consent documents
- Adverse event or safety reporting forms
Selection of trial sites and study team, What are the requirements of the clinical investigators?
Clinical investigators must be:
- qualified
- have sufficient resources
- appropriately trained staff to conduct the investigation
- knowledgeable of the national setting
- circumstances of the site and study population (s).
What is the sponsors responsibility during the selection of trial sites and study team? How should they select clinical trial investigators?
Sponsors should review the requirements of the study protocol to determine the type of expertise required and identify clinical investigators who have the particular medical expertise necessary to conduct the study and who have knowledge, training and experience in the conduct of clinical trials and human subject protection
What is the criteria for site selection?
- Ability and experience of principle investigator (experience in clinical trial/ right expertise)
- Dedicated, trained, experienced study coordinator
- Access to appropriate patient population
- Reputation (refers to quality of studies, not too many clinical deviations, able to meet the timeline, contribute to the committed patient numbers)
- Cooperation
- Accessibility of the site
- Geographic concerns (able to reach out to the right group of patients)
- Facilities and equipment
- Time and cost factors (complete the studies in time, work load, budgeting)
- Honesty and integrity
Assessment Areas to Evaluate: (site selection)
- Investigator/site selection
- Training
- Managing responsibilities
- Scheduling
- Space
- Equipment
- Liaison
- Drug storage
- EC/ regulatory issues
- Contractual agreements
- Protocol compliance, CRF management
- Document management
- Communication
- Recruitment planning
- Data Handling
List the support systems and tools to facilitate the conduct of the study and collection of
data required by the protocol:
- Trial-related information documents (e.g Investigator’s brochure (IB)/ product leaflet, CRFs case report forms, checklists, drug accountability logs (drug dispensing logs)
- Computer software and hardware (randomized system/eCRF)
- Electronic patient diaries (drug administration)
- Other specialized equipment (e.g ECG machine/ BP/ Spirometry(lung function test)
Who takes the responsibility of obtaining IEC/IRB review of the study protocol?
The investigator generally assumes responsibility for obtaining IEC/IRB review of the study protocol
-copies of any approval/ favorable opinion are then provided to the sponsor
What must the studies seek prior to enrolment of study subjects?
Within GCP, studies must be reviewed and receive approval/ favorable opinion from an (IEC) Independent Ethics Committee/ (IRB) Institutional Review Board prior to enrolment of study subjects
