CRP 100 Lecture 8

Question 1

project management defintion

Answer 1

application of skills, tools, and techniques to a broad range of activities in order to meet the requirements of a project

Question 2

5 stages of project management

Answer 2

-initiating
-planning
-executing
-monitoring
-closing

Question 3

initiating project

Answer 3

-define prject
-project charter, document for written approval
-defined by protocol

Question 4

Planning project

Answer 4

doc preparation (ICF, CRF), training staff, procedures, risk analysis, recruitment strategies, TMF,supplies/equitptment, facility, timelines, budget, delegation, responsibilities
-development of project plans to meet project objective
-SOPs

Question 5

Executing project

Answer 5

-conduct project and meet objectives
-execute protocol, recrutiment plans, obtain ethical and regulatory approval, data collection, SOPs, vendors and suppliers
-communications, performance data,team performance
-events and timelines
-enrolement, changes in eligibility
-managing study drug and supplies
-monitoring data, protocol deviations, CAPA
-AE SAE reporting

Question 6

recrutiment strategies (5)

Answer 6

-who is pop
-where are participants from (hospital, etc)
-communiations with participants
-retinaing participants
-metrics to identify and solve challenges

Question 7

monitoring/controlling project

Answer 7

-track and review progress and performance, manage variance
-change logs, schedule and cost forecast, plan updates, QC, deliverables
-monitoring data, safety monitoring, monitor milestones i.e. first patient enrolled, data base lock, CAPA

Question 8

closing project management

Answer 8

-finialize activies and formally close project
-all assessments, tests, procedures, data is complete for all enrolled participants
-other stages include data management, report writing, up to submitting data for market approval before study is actually finished

Question 9

investigator and delegation

Answer 9

-delegation of significant trial related duties (eligibility, dosing, drug handling, AE collection/assessment
-administrative functions (project management, finances)
-cannot exeed person’s license or scope of practice
-may be limited by protocol
-must be documented with qualitifications and signed by PI and delegated party BEFORE performing task
-may have time frame
-filed in regulatory binder

Question 10

qualified meaning

Answer 10

qualified by education, training and experience, all documented

Question 11

education

Answer 11

CV, diploma/degree, licenses

Question 12

training

Answer 12

external training on CV and supported, internal training records, internal study specific training in study file

Question 13

experience

Answer 13

-job description/CV, evaluation of training in training records

Question 14

CV

Answer 14

must be present for all staff on study
-PI and key personnel CV kept in regulatory binder
-must be updates every 2 years or when significant changes occure

Question 15

training records

Answer 15

-training should be reporducible (all trainees same competence)
-documented and retained, 25 yrs
-critical and task based with evaluation (test, observation period)
-trainers qualified and designated
-training filing system are autiable recorids, easy to retrieve, GCP/GDP docs