standard operating procedure (sop) index page – internal - Accord

STANDARD OPERATING PROCEDURE (SOP) INDEX PAGE – INTERNAL
SOP
Effective
SOP Title
number
Date
Review Date Version Attachments
QA001 SOP Preparation and Control. 22/MAR/11 22/MAR/13 2.0 QA001-F01 – SOP Training
QA001-T01 – SOP Template
QA001-T02 – WI Template
QA002 Audit Preparation, conduct and reporting 27/FEB/12 27/FEB/14 1.3 QA002-W01 – Study Specific Audit
QA002-W02 – Internal Systems Audit
QA002-W03 – Facility Audit
QA002-T01 – Audit Notification
QA002-T02 – Audit Plan
QA002-T03 – Audit Checklist/Prompt
QA002-T04 – Audit Interview Script
QA002-T05 – Audit Report
QA002-T06 – Audit Certificate
QA003 Risk Analysis 09/NOV/12 09/NOV/14 2.1 QA003-T01 – Risk Assessment – Internal
Systems
QA003-T02 – Risk Assessment – Facilities
QA003-T03 – Risk Assessment – Studies
QA003-T04 – Risk Schedule – Internal
Systems/Facilities
QA003-T05 – Risk Schedule – Studies
QA003-F01 – Risk Transfer
QA003-F02 – Risk Assessment: Prequalification
QA004 Study Document Review 22/MAR/11 22/MAR/13 1.0 QA004-T01 – Protocol Checklist
QA004-T02 – PIS/CF Checklist
QA004-T03 – CSR Checklist and
ACCORD
Effective
Date
22/MAR/11
22/MAR/11
22/MAR/11
27/FEB/12
22/MAR/11
22/MAR/11
22/MAR/11
22/MAR/11
22/MAR/11
22/MAR/11
22/MAR/11
27/FEB/12
22/MAR/11
22/MAR/11
27/FEB/12
22/MAR/11
27/FEB/12
22/MAR/11
27/FEB/12
22/MAR/11
22/MAR/11
22/MAR/11
2.0
2.0
2.0
2.0
1.1
1.1
1.1
2.0
1.1
1.1
1.1
2.0
1.1
1.1
2.1
1.1
1.2
1.1
1.0
1.0
1.0
1.0
Version
Internal SOP Index
Jan 2013 1 of 3

SOP
number
SOP Title
Effective
Date
Review Date Version Attachments
Effective Version
Date
BS60001 sampling
QA004-T04 – Work plan checklist 22/MAR/11 1.0
QA005 Performance Indicators 22/MAR/11 22/MAR/13 1.1 QA005-T01 – Performance indicator
measurements
22/MAR/11 1.1
QA006 Hosting an Audit or Inspection of ACCORD 22/MAR/11 22/MAR/13 1.0
HR001 Establishing and Maintaining a training record 12/AUG/11 12/AUG/13 1.0 HR001-T01 – Staff Training Record 12/AUG/11 1.0
HR002 Staff Induction, training and continuity 12/AUG/11 12/AUG/13 1.0
HR003 Clinical monitoring competency 21/MAY/12 21/MAY/14 1.0 HR003-F01 – Monitoring Competency
record
Study evaluation 07/MAY/12 07/MAY/14 1.2 GS001-W01 – Agreement Preparation –
GS001
Sponsor
GS001-W02 – Research Review
GS001-W03 – Scientific and Risk
Assessment Meeting
GS001-W04 – Agreement Preparation –
Host
GS001-W05 – Amendments
GS001-F01 – SARA review form
GS001-F02 – Governance Review
Checklist
GS001-F03 – Amendments checklist
GS001-T01 – MA Template &optional
inserts
21/MAY/12 1.0
25/APR/11
07MAY/12
01/FEB/12
25/APR/11
15/FEB/2012
21/MAY/12
21/MAY/12
15/JAN/13
01/MAR/12
1.0
2.1
2.0
1.0
1.0
1.3
1.2
1.2
3.1
GS002
FA001
Combined risk analysis 09/NOV/12 09/NOV/14 1.0 GS002-T01 – Combined risk assessment 09/NOV/12 1.0
Facilitating a research project 25/APR/11 25/APR/13 1.0 FA001-T01 – Clinical investigational agent
classification
FA001-T02 – Clinical investigational agent
flowchart
25/APR/11
25/APR/11
1.0
1.0
ACCORD
Internal SOP Index
Jan 2013 2 of 3

SOP
number
SOP Title
Effective
Date
Review Date Version Attachments
FA001-T03 – Facilitation checklist
FA001-T04 – Quality and safety checklist
FA001-W01 – Clinical investigational
agent identification
Effective
Date
12/AUG/11
25/APR/11
25/APR/11
2.0
1.0
1.0
Version
CM001
CM002
CM003
Site initiation visits 14/SEP/11 14/SEP/13 1.0 CM001-T01 – SIV & green light report 14/SEP/11 1.0
Site monitoring visits 14/SEP/11 14/SEP/13 1.0 CM002-T01 – Site monitoring visit report 14/SEP/11 1.0
Close out visits 14/SEP/11 14/SEP/13 1.0 CM003-T01 – Close out visit checklist
CM003-T02 – Close out visit report
CR = Clinical Research QA = Quality Assurance CM = Clinical Monitoring
W = Work Instruction
T = Template
F = Form
HR = Human Resources
GS = Governance and Sponsorship
FA = Facilitation
14/SEP/11
14/SEP/11
1.0
1.0
ACCORD
Internal SOP Index
Jan 2013 3 of 3