Study conduct
201 Responsibilities of Study Personnel and Appointment, Replacement and Responsibilities of Study Directors and Principal Investigators
205 Laboratory Reagents
208 Data Recording and Management
209 Test Sample Management
231 Test and Reference Items and Standards
243 Study Quality Control (QC) checks
247 Routine Analysis, Repeat Analysis and Incurred Sample Reanalysis
248 Operation of LC-MSMS analysers
252 EDAMS: Routine Use
Study documentation
203 Non-clinical Study Plans
207 Multi-Site Studies
212 Study Reports
244 Clinical Analyses and Clinical Analytical Plans (CAP)
Events
245 Action for Unexpected Events, Deviations and CAPA
246 Alert Reporting
247 Routine Analysis, Repeat Analysis and Incurred Sample Reanalysis
261 Backup Generator
Analytical methods
218 Method Validation
219 Management of Methods
242 Method Development
Equipment
206 Operation and Maintenance of Fridges and Freezers
214 Operation and Maintenance of Balances
215 Operation and Maintenance of pH Meters
222 Facility Housekeeping
230 Operation and Maintenance of Pipettors
232 Operation and Maintenance of Centrifuges
233 Op and Maint of Shaker/Incubator, rotators, vortexers
236 Equipment Operation: General Requirements
237 Operation and Checking of Thermometers
253 Operation and Maintenance of Water Purification Units
256 Sample Concentrator
258 Freezer Alarm System
264 Operation and Maintenance of Thermo ULT Freezers v02
IT
226 Validation of Computer Systems
234 Use of IT Systems and Facilities
249 Electronic Data Transfers
250 Computer Validation Test Script Execution
251 Management and administration of the UoAGLPTF Computer Systems
259 Use of the NuGenesis LMS
Management and archiving
201 Responsibilities... Study Directors and PIs
202 Maintenance of Master Schedule
216 Archive Transfer and Withdrawal
217 Archive Operation
221 SOP Preparation and Management
225 Contracts, Contractors and Service Providers
227 External Inspections and Visits
228 Training and Training Records
235 Business Continuity and Disaster Recovery
261 Backup Generator
263 Document Scanning for Retention and Backup
Quality assurance
204 Check of Plans and Protocols by QA
210 QA Inspections and Audits
213 Report Audit
255 Computer Validation Audit
260 QA Procedures for Report Numbering, Classification and Escalation of Findings
262 Deviation and CAPA tracking
SOP list with current effective dates
List of reissued SOPs
To indicate that you have read one or more electronic SOP(s), please sign the red book if you can, or list them with version numbers in an email to the SOP Coordinator. |