CRO  XYZ  
Sponsor Project Number: 123-765-11 CRO Project Code: 878-2017
Sponsor Name: Pharma Company A

SOP Group: Biometrics Applicable to Yes ⌧ No "

Project?
SOP Number / SOP Title Effective date Applicable Effective To: Location of
Version of SOP: to Project Document *
Number Yes/No?

BI-01-04 Statistical Input to Protocol 15-Oct-2008 Yes 15-Oct-2012

BI-02-04 Clinical Trial Randomization 29-Aug-2008 Yes 29-Aug-2010
BI-03-04 Creating the Statistical Analysis Plan 18-Jul-2008 Yes 18-Jul-2010
BI-04-04 Statistical Analysis of Clinical Trials 30-Nov-2009 Yes 30-Nov-2011
Data
BI-05-04 Interim Analysis of Clinical Trials 11-Dec-2009 Yes 11-Dec-2012
BI-06-07 Statistical Programming Standards 18-May-2009 Yes 18-May-2011
BI-07-04 Statistical Programming Validation 30-Jul-2008 Yes 30-Jul-2012
BI-09-04 Unblinding the Study for Statistical 05-Jan-2009 Yes 05-Jan-2011
Analyses
BI-10-03 Statistical Reports 11-Nov-2008 Yes 11-Nov-2010
BI-11-02 Creation and Maintenance of the 09-Oct-2009 Yes 09-Oct-2011
Requirements Document
BI-12-01 Sample Size Determination 14-Aug-2009 Yes 14-Aug-2012
BI-16-01 Independent Data Monitoring 11-Sep-2009 Yes 11-Sep-2011
Committees
WP BI-01-00 Statistical Programming Guidelines 08-Sep-2008 Yes 08-Sep-2010

Applicable SOPs.doc Page 1 of 13

  
CRO  XYZ  
SOP Group: Clinical Operations Applicable to Yes ⌧ No "
Project?

SOP Number / SOP Title Effective date Applicable Effective To: Location of
Version Number of SOP: to Project Document *
Yes/No?
CO-01-05 Selection of Investigative Sites 26-May-2009 Yes 26-May-2011
CM-01-00 Pre-Study Site Visit 11-Dec-2009 Yes 11-Dec-2012
CM-02-00 Site Initiation Visit 11-Dec-2009 Yes 11-Dec-2012
CM-03-00 Monitoring Visit 11-Dec-2009 Yes 11-Dec-2012
CM-04-00 Close-Out Visit 11-Dec-2009 Yes 11-Dec-2011
CO-08-05 Source Data Verification 20-Mar-2009 Yes 20-Mar-2011
Case Report Form Retrieval and Yes
CO-09-04 05-Nov-2007 05-Nov-2010
Transmittal
Investigational Product Yes
CM-05-00 19-Feb-2010 19-Feb-2011
Accountability
Selection of an Investigational No 22-Jan-2010
CO-12-04 Product Storage and Shipment 22-Jan-2008
Facility
CO-13-04 Selection of a Central Laboratory 22-Jan-2008 Yes 22-Jan-2010
Selection of a Central Institutional Yes
CO-14-04 27-Feb-2009 27-Feb-2011
Review Board or Ethics Committee
CO-15-03 Financial Disclosure Policy 10-Dec-2007 Yes 10-Dec-2010
CO-17-04 Operations Manual 01-Jul-2008 Yes 01-Jul-2011
Storage and Handling of Yes
CO-18-00 GE 30-Apr-2007 30-Apr-2010
Investigational Product
CO-19-00 Monitoring Plan 13-Aug-2008 Yes 13-Aug-2011
Investigational Product Relabeling Yes 01-Apr-2012
WP CM-01-00 01-Apr-2010
at Site

Applicable SOPs.doc Page 2 of 13

  
CRO  XYZ  
SOP Group: Computer System Validation Applicable Yes " No ⌧
to Project?

SOP Group: Data Management Applicable Yes ⌧ No "

to Project?

SOP Number / SOP Title Effective date Applicable Effective To: Location of
Version Number of SOP: to Project Document *
Yes/No?
DM-08-07 Data Lock and Freeze 09-Dec-2008 Yes 09-Dec-2011
DM-09-07 Data Management Plan 20-Mar2009 Yes 20-Mar2012
Database Security, Access and Yes
DM-20-05 03-Nov-2008 03-Nov-2012
Roles
Global Library Administration for Yes 20-Aug-2010
DM-22-03 20-Aug-2008
Oracle Clinical
Developing a Database Application Yes 15-Jan-2013
DM-24-06 15-Jan-2010
for Oracle Clinical
Logging Case Report Form Yes
DM-27-05 13-Mar-2009 13-Mar-2011
Documents
DM-28-06 General Data Entry Process 20-Mar-2009 Yes 20-Mar-2011
Electronic Data Handling from Yes
DM-29-05 23-Oct-2009 23-Oct-2012
External Source
Clinical Data Program Creation and Yes
DM-30-05 16-Oct-2008 16-Oct-2011
Testing
DM-31-05 Discrepancy Management 09-Sep-2008 Yes 09-Sep-2010
DM-32-05 Batch Process Management 30-Jul-2008 Yes 30-Jul-2011
DM-34-05 Data Transfers 20-Nov-2009 Yes 20-Nov-2013
DM-36-05 Quality Management 03-Nov-2008 Yes 03-Nov-2012
DM-40-06 e-TMF Scan and Index 13-Mar-2009 Yes 13-Mar-2011
Post-Freeze Data Modification Yes
DM-46-04 29-Sep-2008 29-Sep-2011
Process
DM-47-04 Medical Coding 03-Nov-2008 Yes 03-Nov-2011
Data Collection Tool Development, Yes
DM-48-05 19-Mar-2010 19-Mar-2012
Review and Approval

Applicable SOPs.doc Page 3 of 13

  
CRO  XYZ  
Serious Adverse Event Yes
DM-50-03 23-Sep-2008 23-Sep-2012
Reconciliation
Developing a Database Application No
DM-51-01 09-Jan-2008
for SAS DMS
Tracking Case Report Form / Data Yes
DM-52-01 20-Oct-2006 20-Oct-2010
Management Status
DM-53-01 Data Cleaning for SAS DMS 28-Sep-2007 No
Returning Case Report Form Yes
DM-55-02 18-Sep-2009 18-Sep-2011
Documents
DM-60-02 Modifying a Database 09-Oct-2008 Yes 09-Oct-2012
Developing a Database Application Yes
DM-61-01 for Oracle Clinical Remote Data 26-Mar-2010 26-Mar-2013
Capture (RDC)
DM-62-00 CROTrial CRF Design 29-Nov-2006 Yes 29-Nov-2010
DM-63-01 CROTrial Database Set-up (SQL) 15-Dec-2008 Yes 15-Dec-2011
DM-64-00 CROTrial Control of CRF Flow 29-Nov-2006 Yes 29-Nov-2010
DM-65-01 CROTrial Data Entry 15-Dec-2008 Yes 15-Dec-2011
29-Nov-2006 Yes
DM-66-00 CROTrial Query Process Reviewed on 29-Nov-2011
08-Oct-2008
29-Nov-2006 Yes
DM-67-00 CROTrial Data Change Requests Reviewed on 29-Nov-2011
08-Oct-2008
29-Nov-2006 Yes
DM-68-00 CROTrial Post Marketing Studies Reviewed on 29-Nov-2011
08-Oct-2008
DM-69-01 DataFax Database Closure 13-Mar-2009 Yes 13-Mar-2012
Study Database Lifecycle (SDLC) Yes
DM-70-01 13-Mar-2009 13-Mar-2011
for DataFax
Developing a Study Database Yes
DM-71-01 13-Mar-2009 13-Mar-2012
Environment in DataFax
Database Design and Yes
DM-72-01 13-Mar-2009 13-Mar-2011
Development for DataFax
Database Testing and Validation Yes
DM-73-01 13-Mar-2009 13-Mar-2012
for DataFax
DM-74-01 Moving a Study Database Into 13-Mar-2009 Yes 13-Mar-2012

Applicable SOPs.doc Page 4 of 13

  
CRO  XYZ  
Production for DataFax
Validation Programming and Yes
DM-75-01 13-Mar-2009 13-Mar-2012
Testing in DataFax
DM-76-01 Laboratory Normals for DataFax 13-Mar-2009 Yes 13-Mar-2013
Database Change Control for Yes
DM-77-01 13-Mar-2009 13-Mar-2011
DataFax

SOP Group: General CRO Applicable Yes ⌧ No "

to Project?
SOP Number / SOP Title Effective date Applicable Effective To: Location of
Version Number of SOP: to Project Document *
Yes/No?
Format, Creation, Revision and Yes
Approval of SOPs Named in 31-Oct-2008 31-Oct-2011
GE-01-08
FileInc: CRO Formal Process
Documentation Management
Retention of Records Relating to Yes
GE-04-06 29-May-2009 29-May-2011
Clinical Research Projects
GE-06-08 Documentation Practices 12-Mar-2010 Yes 12-Mar-2013
30-Oct-2006 Yes
Telephone Communications with
GE-07-05 Reviewed on 30-Oct-2010
non-CRO Personnel
14oct2008
Vendor Identification, Review and Yes
GE-09-05 19-Feb-2010 19-Feb-2012
Qualification
Potential Fraud and Misconduct Yes
GE-15-04 12-Mar-2010 12-Mar-2012
(For-Cause) Investigations
Inspections by Regulatory Yes
GE-16-04 25-Nov-2009 25-Nov-2012
Agencies
GE-17-03 CRO Training and Development 24-Nov-2008 Yes 24-Nov-2011
Processing Contract or Work Order Yes
GE-18-03 24-Nov-2008 24-Nov-2011
Changes
Compliance with 21 CFR Part 11: Yes
GE-19-02 26-Feb-2010 26-Feb-2012
WP QA-01
GE-20-01 EU Archiving Procedure 26-Feb-2008 Yes 26-Feb-2012
GE-21-02 Audits of CRO by Sponsors 12-Feb-2010 Yes 12-Feb-2013

Applicable SOPs.doc Page 5 of 13

  
CRO  XYZ  
Corrective and Preventive Action Yes
GE-22-02 18-Sep-2009 18-Sep-2011
Quality Process
GE-23-00 Job Description 26-Aug-2008 Yes 26-Aug-2012
GE-24-00 Curriculum Vitae 21-Apr-2008 Yes 21-Apr-2012
Transfer of Project Responsibilities Yes
GE-25-00 02-Jul-2008 02-Jul-2011
(Staff Transition)
GE-26-00 Approval to Commence Work 27-Feb-2009 Yes 27-Feb-2012
GE-27-00 Review of the Time and Task List 30-Jun-2009 Yes 30-Jun-2012
WP GE-01-01 EU Grant Contracting 01-Jul-2009 Yes 01-Jul-2011
Training Completion process for 24-Nov-2008 Yes 24-Nov-2012
WP GE-03-00
CRO Required Training
LearnSite Learning Management 24-Nov-2008 Yes
WP GE-04-00 24-Nov-2012
System Administration
CRO Required Curriculum Review 24-Nov-2008 Yes 24-Nov-2011
WP GE-05-00
Procedure
POL GE-02-02 Policy on Process Documentation 31-Oct-2008 Yes 31-Oct-2011
POL GE-03-00 CRO Quality Policy 07-Apr-2009 Yes 07-Apr-2012

SOP Group: CRO Global Technology Applicable Yes # No ⌧

to Project?

SOP Group: Legal Applicable Yes ⌧ No "

to Project?
SOP Number / SOP Title Effective date Applicable Effective To: Location of
Version Number of SOP: to Project Document *
Yes/No?
Confidentiality Agreements Review Yes
WP LE-01-00 19-May-2008 19-May-2011
and Signature Process
Sponsor Start-Up Agreements Yes
WP LE-02-00 19-May-2008 19-May-2011
Review and Signature Process
Sponsor Master Service and Yes
WP LE-03-00 Standalone, Study-Specific 19-May-2008 19-May-2010
Agreements Review and Signature

Applicable SOPs.doc Page 6 of 13

  
CRO  XYZ  
Process
Sponsor Task Orders/Work Orders Yes
WP LE-04-00 19-May-2008 19-May-2012
Review and Signature Process
Vendor Agreements Review and Yes
WP LE-05-00 19-May-2008 19-May-2011
Signature Process

SOP Group: CRO Drug Safety Applicable Yes ⌧ No "

to Project?
SOP Number / SOP Title Effective date Applicable Effective To: Location of
Version Number of SOP: to Project Document *
Yes/No?
SA-02-04 Safety Database Change and 05-Feb-2010 Yes 05-Feb-2011
Maintenance
SA-03-01 Postmarketed Safety Surveillance - 07-Apr-2008 Yes 07-Apr-2012
Processing Medical Information
Requests
SA-04-01 Postmarketed Safety Surveillance: 07-Apr-2008 Yes 07-Apr-2010
Adverse Event Case Processing
for Marketed Products
SA-06-01 Postmarketed Safety Surveillance: 07-Apr-2008 Yes 07-Apr-2011
Product Complaint Reports
SA-08-02 Postmarketed Safety Surveillance 30-Oct-2009 Yes 30-Oct-2011
Review of Literature Reports
SA-09-01 Protocol Development for 02-Jun-2008 Yes 02-Jun-2010
Epidemiology Studies
SA-10-01 Study Reports for Epidemiology 05-Jun-2008 Yes 05-Jun-2012
Studies
SA-11-01 Epidemiology Archiving 04-Jun-2008 Yes 04-Jun-2011

SA-12-01 Medical Chart Abstraction for 06-Oct-2008 Yes 06-Oct-2011

Epidemiology Studies
SA-13-01 Analyses of Epidemiology Studies 29-Sep-2008 Yes 29-Sep-2010

SA-15-02 Safety Monitoring Plan 16-Feb-2009 Yes 16-Feb-2011

Applicable SOPs.doc Page 7 of 13

  
CRO  XYZ  
SA-16-03 Clinical Trial Safety Surveillance: 29-May-2009 Yes 29-May-2012
Serious Adverse Event Case
Processing
SA-17-03 Filing and Archiving of Adverse 29-May-2009 Yes 29-May-2011
Event Reports and Project-Specific
Reference Materials
SA-18-02 Submission and Tracking of 20-Nov-2009 Yes 20-Nov-2012
Expedited Safety Reports to
Regulatory Authorities
SA-19-01 Clinical Trial Safety Surveillance: 23-Sep-2008 Yes 23-Sep-2010
Unblinding of SUSARs
SA-20-01 Clinical Trial Safety Surveillance: 05-Feb-2010 Yes 05-Feb-2011
Periodic Safety Reports
SA-21-02 Preparation of Postmarketed 30-Nov-2009 Yes 30-Nov-2011
Aggregate Periodic Reports for
Submission to Global Regulatory
Authorities
SA-24-01 Safety Surveillance: Verification of 07-Nov-2008 Yes 07-Nov-2012
Electronic Systems and Procedure
to Comply with Regulatory
Reporting Deadlines in the Event of
Failure
SA-26-02 Receipt of Adverse Events or 15-Jan-2010 Yes 15-Jan-2012
Product Complaints after Normal
Business Hours
SA-27-01 Pregnancy Reports 26-Nov-2008 Yes 26-Nov-2011

SA-28-01 Monitoring Compliance of 30-Oct-2009 Yes 30-Oct-2012

Expedited Safety Report
Submissions to Regulatory
Authorities
SA-29-01 Clinical Trial Safety Surveillance: 26-Mar-2010 Yes 26-Mar-2011
Urgent Safety Measures
SA-30-00 Coding of CRO Drug Safety Data 28-Aug-2009 Yes 28-Aug-2012

SA-31-00 Retrospective Review of CRO Drug 08-Jan-2010 Yes 08-Jan-2013

Applicable SOPs.doc Page 8 of 13

  
CRO  XYZ  
Safety Individual Case Safety
Reports
SA-32-00 Signal Detection and Evaluation 26-Mar-2010 Yes 26-Mar-2013

SA-33-00 EU Role and Responsibilities of EU 26-Mar-2010 Yes 26-Mar-2012

QPPV
WP SA-01-02 Writing Case Narratives 18-Dec-2009 Yes 18-Dec-2011

WP SA-04-01 Eudravigilance Registration and 22-Jan-2010 Yes 22-Jan-2012

Testing
POL SA-01-02 Global Pharmacovigilance Policy 11-May-2009 Yes 11-May-2011

SOP Group: Medical Affairs Applicable Yes ⌧ No "

to Project?
SOP Number / SOP Title Effective date Applicable Effective To: Location of
Version Number of SOP: to Project Document *
Yes/No?
Creating the Medical Monitoring Yes
MA-01-03 20-Nov-2009 20-Nov-2012
Plan
Final Data Preparation and Inter- Yes
MA-02-02 26-Mar-2010 26-Mar-2011
rater Reliability Report
MA-03-02 Pre-Investigators Meeting Activities 01-Apr-2010 Yes 01-Apr-2012
MA-04-02 Rater Training and Certification 26-Mar-2010 Yes 26-Mar-2013
Central Monitoring Procedures for Yes
MA-05-01 Psychiatric Rater Training 18-Sep-2009 18-Sep-2011
Programs
Outside Business Hours 24/7 Yes
MA-06-00 Emergency Medical Coverage-WP 09-Oct-2008 09-Oct-2010
IET-46
Procedures and Practice of 13-Nov-2009 Yes 13-Nov-2011
MA-07-01
Medical Monitoring
Electronic Definition of Protocols Yes
12-Feb-2010 12-Feb-2012
MA-08-00 for the Computerized
Neuropsychological Test Battery

Applicable SOPs.doc Page 9 of 13

  
CRO  XYZ  
Computerized Neuropsychological 05-Feb-2010 Yes 05-Feb-2012
MA-10-00
Test Battery Data Management
Source Code Management For Yes
05-Feb-2010 05-Feb-2012
MA-11-00 Clinical Training and Assessments
Applications

SOP Group: Medical Writing Applicable Yes ⌧ No "

to Project?
SOP Number / SOP Title Effective date Applicable Effective To: Location of
Version Number of SOP: to Project Document *
Yes/No?
Protocol Development and Yes
MW-01-05 25-Jan-2008 25-Jan-2011
Approval
Clinical Study Report (CSR) Yes
MW-02-05 13-Nov-2009 13-Nov-2011
Development
MW-03-00 Informed Consent Preparation 17-Sep-2007 Yes 17-Sep-2012
MW-04-01 Writing the Subject Narrative 09-Apr-2010 Yes 09-Apr-2013

SOP Group: Quality Assurance Applicable Yes ⌧ No "

to Project?
SOP Number / SOP Title Effective date Applicable Effective To: Location of
Version Number of SOP: to Project Document *
Yes/No?
QA-01-06 Investigator Site Audits 09-Apr-2009 Yes 09-Apr-2011
QA-03-06 Clinical Study Report Audit 25-Nov-2009 Yes 25-Nov-2012
Institutional Review
QA-09-06 Board/Independent Ethics 15-Jan-2010 Yes 15-Jan-2013
Committee Audit
QA-11-06 Systems Audits 16-Oct-2009 Yes 16-Oct-2011
QA-16-05 Database Audit 20-Nov-2009 Yes 20-Nov-2012
QA-17-06 Trial Master File Audit 13-Nov-2009 Yes 13-Nov-2010
Audit of Protocols, Protocol Yes
QA-18-05 Amendment(s), Consent Forms, 18-Sep-2009 18-Sep-2011
Subject/Volunteer Information

Applicable SOPs.doc Page 10 of 13

  
CRO  XYZ  
Leaflets and/or Case Report Forms
Filing and Archiving of Quality Yes
QA-20-04 05-Mar-2010 05-Mar-2012
Assurance Records
Reporting and Distribution of Yes
QA-21-03 30-Oct-2009 30-Oct-2011
Quality Assurance Audits
QA-22-03 Vendor Audits 13-Nov-2009 Yes 13-Nov-2011
QA-24-03 Software Vendor Audits 05-Feb-2010 Yes 05-Feb-2012
QA Review of Computer System Yes
QA-27-02 18-Dec-2009 18-Dec-2012
Validation Documents
QA-28-01 Statistical Analysis Plan Audit 18-Sep-2009 Yes 18-Sep-2013
QA-29-01 Data Management Plan Audit 09-Oct-2009 Yes 09-Oct-2012
QA-30-01 Audit of Statistical Programming 18-Sep-2009 Yes 18-Sep-2013
POL QA-01-02 CRO Quality Assurance Policy 13-Mar-2009 Yes 13-Mar-2013
Audit Management System Yes
WP QA-01-00 01-Dec-2008 01-Dec-2011
Working Practice
QA Coordination of External eTMF 12-Mar-2010 Yes 12-Mar-2012
WP QA-02-00
Audits

SOP Group: Regulatory Affairs (include Applicable Yes ⌧ No "

Central Files) to Project?
SOP Number / SOP Title Effective date Applicable Effective To: Location of
Version Number of SOP: to Project Document *
Yes/No?
Submissions to National Yes
RA-01-03 EU Regulatory Authorities (excluding 15-Dec-2008 15-Dec-2011
Safety Reporting)
Submissions to Independent Ethics Yes
Committees (IEC) or Institutional
RA-02-03 15-Jan-2009 15-Jan-2012
Review Boards (IRB) (excluding
Safety Reporting)
Authorisation for the Release of Yes
RA-03-03 EU 10-Sep-2008 10-Sep-2011
Investigational Medicinal Product
Filing in the Regulatory Affairs Yes
RA-04-02EU 09-Feb-2009 09-Feb-2012
Department
RA-05-02 US Annual Reports for Postmarketing 06-Feb-2008 Yes 06-Feb-2011

Applicable SOPs.doc Page 11 of 13

  
CRO  XYZ  
Reporting
RA-08-02 US IND Annual Reports 06-Feb-2008 Yes 06-Feb-2011
Submission of New Drug Yes
Application/New Biologic
RA-11-02US 06-Feb-2008 06-Feb-2011
Application/Common Technical
Document
RA-15-02 US Essential Documents 30-Nov-2007 Yes 30-Nov-2010
Distribution of Expedited Safety
Reports to Investigator Sites and Yes
RA-25-01 19-Jan-2009 19-Jan-2012
Ethics Committees / Institutional
Review Boards
Tracking and Filing of IND Serial Yes
30-Oct-2009 30-Oct-2012
RA-26-00 Submissions and FDA
Correspondence
Translation of Essential Regulatory Yes
RA-27-00 EU 07-Aug-2007 07-Aug-2010
Documents
03-Nov-2009 Yes 03-Nov-2011
RA-28-00 EU Essential Document Management
Essential Regulatory Document Yes
WP RA-01-01 05-Nov-2007 05-Nov-2010
Processing and Tracking
WP RA-02-00 Drug Release Process Flow 07-Aug-2007 Yes 07-Aug-2011
WP RA-03-00 Central Files 30-Nov-2007 Yes 30-Nov-2010
Paper Trial Master File Content 19-Feb-2010 Yes 19-Feb-2012
CF-01-00
and Management
Electronic Trial Master File Content 19-Feb-2010 Yes 19-Feb-2012
CF-02-00
and Management

Applicable SOPs.doc Page 12 of 13

  
CRO  XYZ  
SOP Group: CRO Applicable Yes ⌧ No #
to Project?
SOP Number / SOP Title Effective date Applicable Effective To: Location of
Version Number of SOP: to Project Document *
Yes/No?
Documentation of Signatures for Yes
RE-01-00 26-Nov-2007 26-Nov-2011
Clinical Study Personnel
Notification of Serious Breaches of Yes
RE-02-01 25-Jun-2008 25-Jun-2011
GCP or the Trial Protocol

SOP Group: CRO Data Management Applicable Yes ⌧ No "

to Project?
SOP Number / SOP Title Effective date Applicable Effective To: Location of
Version Number of SOP: to Project Document *
Yes/No?
CRO DM Records Management 13-Nov-2009 Yes 13-Nov-2011
ST-01-01 US
Operations - Americas
Locating and Saving Documents 18-Dec-2009 Yes 18-Dec-2012
WP ST-01-02
on the Network

Applicable SOPs.doc Page 13 of 13