Overview
The 2009 Clinical Research Quality Management System is a comprehensive collection of statements, policies, procedures, templates, and supporting documents containing everything you need to set up a clinical research function.
Each procedure is designed to tell you 'how to' do something and it results in a work product such as a document or report. The procedures are organized chronologically, the way you would organize a project schedule, to walk you step-by-step through the process of running a clinical trial and a clinical department. The manual is divided into sections that follow the major activities of a clinical project.
You'll receive all the files on CD in an editable Word format (occasionally tables may be provided in Excel or Visio), and the entire content is color-printed and bound in a three-ring binder so you can see what you've got in a pleasing, easy-to-use format.
Stark NJ, Clinical Research Quality Management System, 2009 Edition, Clinical Device Group Inc, Chicago, IL (2009). ISBN: 1-889160-18-0. Compact disk and three-ring bound. $3000 USD.
Here is a list of the files and procedures you'll receive. The attachments are not listed in order to save space, but almost all of the procedures are supported by example forms or templates:
Section 1: The Quality Management System
[x] Quality Policy - Statement of management's commitment to quality clinical research.
[x] Quality Manual - Vision and Mission statements for the clinical research function.
[x] Operations Manual - Workflow charts showing the steps of implementing a clinical trial and how the clinical research function interact with other functions.
[x] Example job descriptions: Director, Senior CRA, and Junior CRA.
[x] SOP Style Manual.
[x] Documentation Matrix.
[x] Communications procedures.
[x] List of SOPs and attachments.
Section 2: The Procedures
Prestudy Tasks
SOP 10.0 Request for Study.
SOP 11.0 Clinical Development Plan.
SOP 12.0 Protocols, including a 30-page template.
SOP 13.0 Case Report Forms.
SOP 14.0 Medical Risk Analyses.
SOP 15.0 Consents, including US and OUS models.
SOP 16.0 Subject Recruitment.
SOP 17.0 Report of Prior Investigations or Literature Reviews.
SOP 18.0 Investigator's Brochures.
SOP 19.0 Design Controls.
SOP 20.0 Regulatory Status.
SOP 21.0 Investigational Device Labeling.
SOP 22.0 Design Release.
SOP 23.0 Sterility Release.
SOP 24.0 Biological Safety Release.
SOP 25.0 Investigational Plans.
SOP 26.0 Screening Investigators.
SOP 27.0 Financial Disclosure--Start of Study.
SOP 28.0 Prestudy Visits.
SOP 29.0 Site n Center Budgets.
SOP 30.0 Investigator Agreements.
SOP 31.0 Clinical Trial Agreements.
SOP 32.0 IRBs n ECs.
SOP 33.0 Investigator's Regulatory Binders.
SOP 34.0 Subject Binders.
SOP 35.0 Monitors Binders.
SOP 36.0 ClinicalTrials.gov.
Study Tasks
SOP 40.0 Study Initiation Visits, plus report template.
SOP 41.0 Monitoring Visits, plus report template.
SOP 42.0 Monitoring Laboratories.
SOP 43.0 Monitoring Queries.
SOP 44.0 Off-Site Monitoring.
SOP 45.0 Inventory Control (i.e., device accountability).
SOP 46.0 Amendments n Deviations.
SOP 47.0 Adverse Events.
SOP 48.0 Site Management
SOP 49.0 Data Monitoring Committees.
Close-Out Tasks
SOP 60.0 Close-out Visits, plus report template.
SOP 61.0 Financial Disclosure--End of Study.
SOP 62.0 Investigator Files.
SOP 63.0 Sponsor Files.
Data Management Tasks: Database Design
SOP 70.0 Database Applications.
SOP 71.0 Database Design.
Data Management Tasks: Data Entry n Analysis
SOP 80.0 Working Datasets.
SOP 81.0 Data Entries n Data Queries.
SOP 82.0 Final Datasets n Data Lock.
SOP 83.0 Statistical Analysis.
SOP 84.0 Annual Reports.
SOP 85.0 Final Reports.
Other Tasks
SOP 90.0 Studies on Healthy, Employee Volunteers.
SOP 91.0 Site Audits.
SOP 92.0 Sponsor Audits.
SOP 93.0 Label Copy Review.
SOP 94.0 Additional Sponsor Responsibilities.
SOP 95.0 Clinical Research Documentation System.
SOP 96.0 Quality System Maintenance.
SOP 97.0 Training Records.
Considering the year or more it will take your people to set up a department on their own, the hundreds of hours involved in creating this manual, and the reputation and expertise of the author, this manual is a rare bargain in today's world.
