Our clinical research quality system contains all the information a sponsor needs to implement an Part 812/ISO 14155 compliant medical device clinical study or to organize and manage an ISO 13485 compliant clinical research department. Absolutely complete, the system comes to you as editable Word, Excel, and Visio files so you can adapt them to your own needs.
Following the strategy of one standard results in one work product, the system consists of 43 separate standards laid out in the chronological order of implementing a study. The standards are complemented by more than 50 annotated templates of forms and reports to guide you through the process of record-keeping. For more details consult our catalog.
Contents
Please note that this item will not be available for shipping until mid-June.
| Stark NJ, Clinical Research Quality System, 2008 Edition, Clinical Device Group Inc, Chicago, IL (2008). Three-ring bound. $1500 US after discount is applied; |
Administrative
Table of contents
Quality system overview
Quality statement
Vision and mission statement
Organization chart
Operations and workflow
Job descriptions
Communications
Clinical Research Documentation System
Training records
Clinical Research Documentation System
SOP style manual
Standard Operating Procedures
Pre-study tasks
01.0 Request for study
-01.1 Request template
02.0 Clinical development plan
-02.1 Clinical development plan template
03.0 Protocols
-03.1 Protocol template
03.2 Protocol Approval Form
04.0 Case report forms
-04.1 CRF diagram
-04.2 CRF List
05.0 Risk analysis
-05.1 Risk analysis worksheet
06.0 Consent forms
-06.1 Consent form checklist--US
-06.2 Consent form checklist--EU
-06.3 HIPAA Authorization template
07.0 Subject recruitment
-07.1 Subject recruitment strategy template
08.0 Report of Priors--US
09.0 Literature Review--EU
10.0 Investigator brochure
-10.1 Investigator brochure checklist
11.0 Design release
12.0 Identity & traceability
-12.1 Identity form
13.0 Investigational device labeling
14.0 Regulatory status of device
-14.1 Regulatory Status form--US
-14.2 Regulatory Status form--EU
15.0 Investigational Plans--US
-15.1 Investigational plan checklist
16.0 Investigator screening
-16.1 Study summary sheet
-16.2 Bilateral Confidentiality agreement
17.0 Prestudy Visits
-17.1 Prestudy Form (check-off version)
-17.2 Prestudy Form (fill-in version)
18.0 Site magement
19.0 Financial Disclosure notice
-19.1 Financial Disclosure notice template
20.0 Investigator Agreement
-20.1 Investigator agreement template
-20.2 Recruitment commitment amendment
21.0 Investigative Site Budgets/Center Budgets
-21.1 Budget worksheet
22.0 Clinical Trial Agreement
-22.1 Clinical trial agreement model
23.0 IRB/EC approval
24.0 Investigator's Regulatory Binder
-24.1 Cover Page
-24.2 Log of Logs
-24.3 Screening Log
-24.4 Enrollment Log
-24.5 Randomization Plan
-24.6 Study Staff Log
-24.7 Monitoring Log
-24.8 15 Tab Table of Contents
25.0 Subject Binders
-25.1 Cover Page
-25.2 Subject Binder Labels
-25.3 Table of Contents
26.0 Monitor's Binder
-26.1 CRF Verification Log
Study tasks
27.0 Study initiation visits
-27.1 Study Initiation Report template
-27.2 NSR-SR checklist
-27.3 Follow-Up Letter template
28.0 Monitoring visits
-28.1 Monitoring Visit Report template
29.0 Monitoring laboratories
-29.1 Clinical laboratory reports
-29.2 In Vivo laboratory reports
30.0 Monitoring queries
-30.1 Monitoring Query form
31.0 Off-site Monitoring
-31.1 Off-site monitoring log
32.0 Inventory Control
-32.1 Inventory Control from .doc
-32.2 Inventory control form .xls
-32.3 Subject Exposure log
33.0 Protocol Departures
-33.1 Protocol Departure form
34.0 Close-Out Visits
-34.1 Close-Out Visit Report template
35.0 Adverse Events
-35.1 Safety Assessment
-35.2 Adverse Event Report--US
-35.3 Adverse Event Report--EU
36.0 Data Monitoring Committiee
-36.1 DMC Charter template
-36.2 DMC Minutes template
-36.3 DMC Final Disclosure template
-36.4 Adjudication Log Template
37.0 Investigator Files
-37.1 Investigator File checklist
38.0 Sponsor Files
-40.1 Sponsor Files checklist
Database tasks
39.0 Database design
-39.1 Comparison of Tables & Records
-39.2 Database Design Strategy
-39.3 Database Specification Plan
-39.4 Database User's manual
-39.5 Database History log
40.0 Database Queries
-40.1 Database Query form
41.0 Working Datasets
-41.1 Data Entry Flowchart (.vsd n .pdf)
42.0 Working Datasets
43.0 Statistical reports
44.0 Clinical reports
45.0 Final reports
Post-study tasks
46.0 Auditing investigational sites
-46.1 Auditing Investigative Sites template
47.0 Auditing Sponsors
-47.1 Auditing Sponsors template
48.0 Financial Disclosure, End of Study
-48.1 Financial Disclosure, End of Study template
49.0 Healthy Employee Volunteers
-49.1 Part 812-Sponsor IRBs.pdf
Other tasks
50.0 Label Copy Review
-50.1 Label Copy Review form
Records and Reports
99.0 Records
99.1 References
99.2 Glossary
99.3 Labels
99.4 Spine