PRL CENTRAL LABORATORY SERVICES
SERVICES OVERVIEW | ANATOMIC PATHOLOGY | QUALITY ASSURANCE
DATA MANAGEMENT | TEST DIRECTORY
QUALITY ASSURANCE: Clinical Trails PRL Central SOP Index
The following procedures are included in this manual:
| CT001.00 | Numbering Standard Operating Procedures (SOP) – Clinical Trials |
| CT101.01 | New Protocol Setup |
| CT102.00 | Creating A Set Up Sheet |
| CT105.00 | Creating a Requisition |
| CT106.02 | Protocol Specifications Document |
| CT106.A1 | Protocol Specification Master Document For Multi-Site Trial |
| CT106.A2 | Example Protocol Specification Amendment |
| CT107.01 | Kit Production Specifications |
| CT107.A1 | Protocol Kit Specifications |
| CT110.01 | Sample Storage and Disposal for a GLP Study |
| CT110.F1 | Chemistry Sample Storage & Disposal Form |
| CT110.F2 | Hematology Sample Storage & Disposal Form |
| CT111.01 | Workflow of a GLP Study |
| CT111.F1 | Modified 1650 QA Form GLP |
| CT112.01 | Master Schedule |
| CT112.F1 | Master Schedule GLP Protocols |
| CT113.02 | Final Study Report – GLP Protocols |
| CT113.F1 | Final Study Report |
| CT114.01 | Final Study Report – Non-GLP Protocols |
| CT114.A1 | Final Study Report |
| CT115.00 | Routine Report Audit |
| CT115.F1 | Report Audit Tally |
| CT115.F2 | Results Report Audit Form |
| CT116.00 | Addition Of Therapeutic Areas To The LIS |
| CT117.00 | Addition Of A Toxicity Grade To The LIS |
| CT118.00 | Addition Of A Phase To The LIS |
| CT120.00 | Addition Of A Custom Report Group To The LIS |
| CT121.00 | Validation of LIS Protocol SetUp |
| CT121.F1 | FastLab Protocol Validation Checklist |
| CT307.04 | PRL FASTLAB – Adding Orders From A Clinical Trials Requisition |
| CT315.05 | Add/Edit/Delete Notes On A Clinical Trials Requisition |
| CT316.05 | PRL FASTLAB – Editing Orders From A Clinical Trials Requisition |
| CT317.05 | Subject Maintenance – Change Subject Demographics |
| CT322.02 | Data Collection, When to Query A Site |
| CT326.01 | Client Issue Report System |
| CT326.F1 | Clinical Trials Client Issue Report Form |
| CT328.01 | Clinical Trials Central/Premier Contingency Plan |
| CT329.00 | Processing Clinical Trials Samples |
| CT332.00 | Management Of Stored Samples For Shipment To Assay Laboratory |
| CT332.A1 | Sample Log |
| CT332.A2 | Specimen Shipping Log |
| CT332.A3 | Example Specimen Labels |
| CT334.00 | PRL fastlab – Dual Entering Orders For A Clinical Trials Requisition |
| PD107.00 | Shipping Diagnostic and Infectious Samples by Air |
| CT400.00 | Electronic Data Transfer |
| CT400.A1 | Electronic Data Transfer Specifications |
| CT400.A2 | Checklist For Data Transfer |
| CT400.A3 | Data Transfer Log |
| CT400.A4 | Laboratory Data Transfer Form |
| CT401.00 | Confidential Reporting |
| CT402.00 | CT Result Inquiry From The PCS Dashboard |
| CT403.00 | Generate A Trend Analysis (Cumulative Report) |
| CT404.00 | Requesting Set Up Of CT Remote Users Through The Help Desk |
| CT404.F1 | Clinical Trials Remote Access Request Form |
| CT500.04 | Monitoring Check-In – And STAT Visits |
| CT515.00 | Troubleshooting The Pending List |
| CT517.00 | Clinical Trials Morning Start-up |
| CT519.00 | Clinical Trials – Password Protecting A File Using Winzip |
| CT600.00 | Clinical Trials Replacement Test Request Form |
| CT601.01 | Filing Clinical Trials Requisitions |
| CT602.00 | Clinical Trials Requisition And Study Files Archive Procedure |