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Study Initiation
The _________ of a newly approved/activated study requests that the study team at the lead site organizes a meeting to review the specifics of the ______ in preparation to enroll the first subject i.e. the science, design, procedures, and ______ completion.
Attendees include?
The sponsor/CRO of a newly approved/activated study requests that the study team at the lead site organizes a meeting to review the specifics of the protocol in preparation to enroll the first subject i.e. the science, design, procedures, and case report form (CRF) completion.
Attendees include: the Overall Principal Investigator, Program Manager, Research Pharmacist, assigned Study Coordinator, and Research Nurse.
Trial Objectives and Purpose
Trial Design
- primary and secondary _______
- description of the _______ of trial to be conducted (e.g. double-blind, placebo-controlled, parallel design) and a schematic _______ of trial design, procedures and stages.
- A description of the measures taken to minimize/avoid _______
- trial _______ and the _______ and _______ regimen of the
investigational product(s).
- primary and secondary objectives/endpoints
- description of the type/design of trial to be conducted (e.g. double-blind, placebo-controlled, parallel design) and a schematic diagram of trial design, procedures and stages.
- A description of the measures taken to minimize/avoid bias
- trial treatment(s) and the dosage and dosage regimen of the
investigational product(s)
- The expected _______ of subject participation, and a description of the _______ and _______ of all trial periods, including follow-up, if any.
- A description of the “_______ rules” or “_______ criteria” for individual subjects, parts of trial and entire trial.
- _______ procedures for the investigational product(s), including the placebo(s) and comparator(s), if any.
- Maintenance of trial treatment _______ codes and procedures for _______ codes.
- The identification of any data to be recorded directly on the _______ (i.e. no prior written or electronic record of data), and to be considered to be source data.
- The expected duration of subject participation, and a description of the sequence and duration of all trial periods, including follow-up, if any.
- A description of the “stopping rules” or “discontinuation criteria” for individual subjects, parts of trial and entire trial.
- Accountability procedures for the investigational product(s), including the placebo(s) and comparator(s), if any.
- Maintenance of trial treatment randomization codes and procedures for breaking codes.
- The identification of any data to be recorded directly on the CRFs (i.e. no prior written or electronic record of data), and to be considered to be source data.
Other important topics:
- Accrual _______ and protocol _______
- _______ responsibilities and _______ analysis
- Informed consent _______
- Protocol-specific _______
- _______ provided
- Supplies and material _______
- Laboratory and sample _______
- Accrual target and protocol timeline
- Financial responsibilities and coverage analysis
- Informed consent language
- Protocol-specific training
- Equipment provided
- Supplies and material procurement
- Laboratory and sample management
Study Procedures Treatment of Subjects:
- The treatment(s) to be _______, including the name(s) of all the _______(s), the _______(s), the dosing _______(s), the _______(s) of administration, and the treatment _______(s), including the _______ period(s) for subjects for each investigational product treatment/trial treatment _______ of the trial.
- _______(s)/_______(s) permitted (including _______ medication) and not permitted before and/or during the trial.
- Procedures for monitoring subject _______.
- The treatment(s) to be administered, including the name(s) of all the product(s), the dose(s), the dosing schedule(s), the route/mode(s) of administration, and the treatment period(s), including the follow-up period(s) for subjects for each investigational product treatment/trial treatment group/arm of the trial.
- Medication(s)/treatment(s) permitted (including rescue medication) and not permitted before and/or during the trial.
- Procedures for monitoring subject compliance.
Study Assessments
Assessment of Study Efficacy
- Specification of _______ parameters
- Methods and timing of _______, _______ and _______ of efficacy parameters
Assessment of Safety
Methods and timing of _______, _______ and _______ of safety parameters
Procedures for eliciting _______ and for recording and reporting _______ events and intercurrent _______
_______ and _______ of the follow up of subjects after adverse events
- Specification of efficacy parameters
- Methods and timing of assessing, recording and analysis of efficacy parameters
- Specification of safety parameters
Methods and timing of assessing, recording and analysis of safety parameters
Procedures for eliciting reports and for recording and reporting adverse events and intercurrent illnesses
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