59 terms

SOP

STUDY
PLAY
IS01
Software Validation
IS02
Anti Virus Software
IS04
Disaster Planning
IS05
Equipment Management
IS06
Programming
IS07
Security *requires annual review*
IS08
Managing MACRO Database Users and Roles
IS11
MACRO Auto Insert Application
IS12
Computer System Change Management
IS13
Trial Systems Access- this is down as all staff on the front page of the SOP- update now? Needs primary link too (create a new version with update)
IS14
Gen24 Service Development
IS15
IT Induction
IS16
DLL Development and Deployment
IS17
Computer User Accounts
IS18
Implementing reports
IS20
Server Infrastructure Management
IS21
Data Backup and Restore
IS22
Compliance Report
M01
CTRU SOPs
M03
CTRU Guidelines
M05
CTRU Work Instructions
M06
CTRU Standard Documents
M07
CTRU Training Records
M08
Archiving
M09
Using the CTRU SOP 2006 System-
QA01
CTRU Internal Audit
QA02
Notification and Review of External Audits
QA03
Regulatory and Governance Communication and CTRU Meetings
QA04
QA Document Processing
S01
Statisticians' Roles and Responsibilities
S02
Statistician's Training
S03
Statistical Quality Assurance Checks
S04
Analysis Plans
S05
Statistical Interim Analysis
S06
Roles and Requirements in Double Blind Studies
T01
Risk Assessment Management and Monitoring
T02
Trial Delivery and Independent Oversight
T03
Contract Review & Approval
T04
Reviewing, Agreeing and Approving the Protocol and Related Documents
T05
Amendments to Ethically and/or Regulatory Approved Trials and Documents
T06
Site Feasibility and Initiation
T07
MACRO Database Design and Implementation
T08
CTRU Site Monitoring
T09
Randomisation
T10
Pharmacovigilance
T11
CRF Design and Development
T13
Safety Reporting for Non-CTIMP Trials
T14
Deleting Subjects from a MACRO Database
T15
Investigational Medicinal Product Management
T16
Trial and Trial Site Closure
T17
Participant Withdrawal
T18
Serious Breaches of GCP or Protocol and Urgent Safety Measures
T19
Informed Consent
T20
Reports, Specification and testing- requires a primary link T01
T21
Clinical Trial Samples (biobank)- requires a primary link T01
T23
Data Transfer
T25
Dose escalation review and approval
T30
Essential Document Management
T31
Roles and Requirements in Double Blind Trials
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