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9fb1b313-9097-4eaf-b86e-b838c5166dfc.xls Page 1
Kigali Lusaka Kitwe Ndola Review Point
Version Number Date of Last
SOP Number SOP Title Effective Effective Effective Effective Person (Date
and Date Review
Date Date Date Date Assigned)
MGMT 1 SOP on SOPs 2.0 9Apr2008 9-Apr-08
Ethics Committee
MGMT 2 Submissions and 2.0 9Jan2008 9-Jan-08
Reporting
Maintaining
MGMT 3 Investigator Master 2.0 9Jan2008 9-Jan-08
File
Documenting Roles
MGMT 4 and Responsibilities 1.0 6Oct2005
MGMT 5 General Operating 2.0 9Jan2008 9-Jan-08
Procedures for the Unit
Site Organograms 27-Feb-08
Communication with
MGMT 6 Key Personnel and 1.0 6Oct2005
Protocol Team
Establishment and
Maintenance of
MGMT 7 2.0 30Apr2007 30-Apr-07
Investigator and Staff
Training Records
Appendix 7: Revised
RZHRG Training Sign-
In Sheet
Informed Consent
MGMT 8 Development and 1.0 08May2007 8-May-07
Review/Approval
MGMT 9 Power Failure 2.0 30Jan2008 30-Jan-08
To be retired
MGMT 13 Human Subjects 1.0 29Nov2006 and replaced Marielysse
Education Program with MGMT15
Corrective Action for
MGMT14 Non-Lab Protocol 1.0 15Aug2007 15-Aug-07
Events
MGMT SOPs Page 1 of 17
9fb1b313-9097-4eaf-b86e-b838c5166dfc.xls
Kigali Lusaka Kitwe Ndola
Version Number Date of Last
SOP Number SOP Title Effective Effective Effective Effective
and Date Review
Date Date Date Date
Cash Transactions -
ADMIN 1 Local Currency 1.0 29Nov2006 29-Nov-06
Cash Transactions -
ADMIN 2 US Dollars 1.0 29Nov2006 29-Nov-06
ADMIN 3 Check Transactions 1.0 29Nov2006 29-Nov-06
Field Letter
ADMIN 4 Preparation 1.0 29Nov2006 29-Nov-06
Preparation of
ADMIN 5 Salaries 1.0 29Nov2006 29-Nov-06
ADMIN 6 New Employees 1.0 29Nov2006 29-Nov-06
ADMIN 7 Departing 1.0 29Nov2006 29-Nov-06
Employees
Bank Account
ADMIN 8 Numbers 1.0 29Nov2006 29-Nov-06
ADMIN 9 Bank Transactions 1.0 29Nov2006 29-Nov-06
ADMIN 10 Per Diem 1.0 29Nov2006 29-Nov-06
ADMIN 11 Interns 1.0 29Nov2006 29-Nov-06
ADMIN 12 Students 1.0 29Nov2006 29-Nov-06
ADMIN 13 Visitors 1.0 29Nov2006 29-Nov-06
ADMIN 14 Work Permits 1.0 29Nov2006 29-Nov-06
ADMIN 15 Driver's Licenses 1.0 29Nov2006 29-Nov-06
On Call
ADMIN 16 Responsibilities 1.0 20Nov2006 20-Nov-06
ADMIN 17 Project Pets 1.0 14Nov2006 14-Nov-06
ADMIN SOPs
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9fb1b313-9097-4eaf-b86e-b838c5166dfc.xls
Kigali Lusaka Kitwe Ndola
Version Number Date of Last
SOP Number SOP Title Effective Effective Effective Effective
and Date Review
Date Date Date Date
ADMIN 18 Vehicles 1.0 14Nov2006 14-Nov-06
Preparation of
ADMIN 19 Pension Payments 1.0 29Nov2006 29-Nov-06
Preparation of Tax
ADMIN 20 Payments 1.0 29Nov2006 29-Nov-06
Healthcare for
ADMIN 21 Zambia Field 1.0 12Feb2007 12-Feb-07
Personnel
ADMIN 22 Ordering Supplies 1.0 15Aug2007 15-Aug-07
Appendix 1: Supply
Order Form
ADMIN 23 1.0 29Nov2006 29-Nov-06
Grievance Procedure
ADMIN 24 1.0 29Nov2006 29-Nov-06
Disciplinary Code
Healthcare for
ADMIN 25 Rwanda Field 1.0 12Feb2007 12-Feb-07
Personnel
ADMIN SOPs
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9fb1b313-9097-4eaf-b86e-b838c5166dfc.xls
Site in charge
of revision
KIGALI
KIGALI
KIGALI
LUSAKA
LUSAKA
LUSAKA
LUSAKA
COPPERBELT
COPPERBELT
KIGALI
COPPERBELT
LUSAKA
KIGALI
LUSAKA
LUSAKA
LUSAKA
COPPERBELT
ADMIN SOPs
Page 4 of 17
9fb1b313-9097-4eaf-b86e-b838c5166dfc.xls
Site in charge
of revision
KIGALI
KIGALI
KIGALI
LUSAKA
LUSAKA
ADMIN SOPs
Page 5 of 17
9fb1b313-9097-4eaf-b86e-b838c5166dfc.xls
Version
Kigali Effective Lusaka Kitwe Effective Ndola Effective Date of Last
SOP Number SOP Title Number and
Date Effective Date Date Date Review
Date
Preparing/Maintaining
DATA 1 Source Documents 1.0 6Oct2005 6-Oct-05
Data Management
DATA 2 (PIP Specific) 2.0 19Jul2006 19-Jul-09
Use of Information
DATA 3 and Communication 1.0 6Oct2005 6-Oct-05
Technology
Computer Data
DATA 4 Security and Backup 1.0 6Oct2005 6-Oct-05
Plans
Protection of
DATA 5 Volunteer Privacy 2.0 9Jan2007 9-Jan-07
Data Entry and
DATA 6 Validation 2.0 30Mar2006 30-Mar-06
Data Query
DATA 7 Guidelines 1.0 6Oct2005 6-Oct-05
Archiving and Storage
DATA 8 2.0 30Jan2008 30-Jan-08
of Study Data
Appendix A-C and E-
I: Archiving and 2.0 30Jan2008 30-Jan-08
Storage of Study Data
Appendix D: Sample
2.0 30Jan2008 30-Jan-08
of Box Label
Data and
DATA 11 Administrative File 1.0 26Aug2008 26-Aug-08
Transfer
DATA SOPs
Page 6 of 17
9fb1b313-9097-4eaf-b86e-b838c5166dfc.xls
Version Number Kigali Effective Lusaka Kitwe Effective Ndola Effective Date of Last Site in charge
SOP Number SOP Title
and Date Date Effective Date Date Date Review of revision
CLINIC 1 Obtaining 3.0 08May2007 8-May-07
Informed Consent
HIV Counseling
CLINIC 2 and Risk 3.0 03Aug2006 3-Aug-06
Reduction KIGALI
Reporting Serious
CLINIC 3 Adverse Events 2.0 16Jan2008 16-Jan-08
Participant
CLINIC 4 Recruitment 2.0 19Jul2006 19-Jul-06
KIGALI
Determining
CLINIC 5 Eligibility 2.0 16Jan2008 16-Jan-08
Study Participant
CLINIC 6 Retention 2.0 19Jul2006 19-Jul-06
LUSAKA
ZEHRP CW
Interim Letter 5-Nov-07
ZEHRP CW Late
Letter 5-Nov-07
ZEHRP CW 5-Nov-07
Reschedule Letter
PSF CW Letter 20-Nov-06
Specimen
Collection and
CLINIC 7 Universal 2.0 13Apr2007 13-Apr-07
Precautions
Medical
CLINIC 8 Emergencies 2.0 19Feb2007 19-Feb-07
HIV Post
CLINIC 9 Exposure 3.0 08Sep2008 8-Sep-08
Prophylaxis
Partners/HT
CLINIC 10 Study Integration 2.0 23Aug2006 23-Aug-06
(PIP only) PIP STUDY DO NOT UPDATE
CLINIC SOPs
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Version Number Kigali Effective Lusaka Kitwe Effective Ndola Effective Date of Last Site in charge
SOP Number SOP Title
and Date Date Effective Date Date Date Review of revision
HSV/Protocol C
Specimen
CLINIC 11 Collection & 2.0 25Sep2006 25-Sep-06
Participant
Transfer (all sites) PIP STUDY DO NOT UPDATE
Appendix 1:
Copperbelt 5-Jan-06
specimen flow
Appendix 2:
Kigali/Lusaka 15-Oct-06
specimen flow
HSV Counseling
CLINIC 12 and Risk 2.0 13Feb2008 13-Feb-08
Reduction
CLINIC 13 Clinic On Call 2.0 13Feb2008 13-Feb-08
Photographing
CLINIC 15 Post Vaccination 1.0 20Mar2006 13-Mar-08
Related Lesions
Use of the Coital
CLINIC 16 Calendar 1.0 15Nov2006 15-Nov-06
KIGALI
Couples HIV
Voluntary
CLINIC 17 Counseling and 2.0 11May2007 11-May-07
Testing (CVCT)
Procedures
CLINIC 18 Deceased Protocol 1.0 12Dec2007 12-Dec-07
CLINIC SOPs
Page 8 of 17
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Review Point
Version Number Kigali Effective Lusaka Kitwe Effective Ndola Effective Date of Last
SOP Number SOP Title Person (Date
and Date Date Effective Date Date Date Review
Assigned)
Use and Maintenance of
PHARM 2 the Laminar Flow Hood 3.0 18Apr2007 8-Feb-08
Administration Using
PHARM 3 Biojector 1.0 06Oct2005 8-Feb-08
Prescribing and
PHARM 4 Dispensing Investigational 2.0 16Aug006 8-Feb-08
Product
PHARM 5 Storage of Study Products 1.0 06Oct2005 8-Feb-08
Temperature and
PHARM 6 Humidity Monitoring of 3.0 18Apr2007 8-Feb-08
Storage Work Areas
Appendix 2: Temperature
Monitoring Graphs
(including electronic temp 3.0 18Apr2007 8-Feb-08
monitoring template)
Study Product
PHARM 7 Accountability/Inventory 1.0 06Oct2005 8-Feb-08
Emergency Transfer of
PHARM 8 Investigational Products 1.0 06Oct2005 8-Feb-08
PHARM SOPs
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Version Number Kigali Effective Lusaka Effective Kitwe Effective Ndola Effective Date of Last
SOP Number SOP Title
and Date Date Date Date Date Review
Training and Safety
LAB 1B 1.0 16Feb2006 16-Feb-06 16-Feb-06
Health and Biosafety in
Laboratory
Personal Competencies and
LAB 1C 1.0 25Apr2007 15-May-07 25-Apr-07
Training for RZHRG
laboratories
Lab Data and Documents
LAB 3B (CL 009.4) LIMS: Data Entry and 2.0 11May2007 28-Sep-08 11-May-07
Sample Inventory
LAB 3D Specimens & Results 2.0 26Sep2008 26-Sep-08
QC/QA
LAB 3F Specimen Audit Trail 2.0 26Sep2008 26-Sep-08
Quality Control
LAB 5A (CL 020.2) Laboratory Quality Program 2.0 25Apr2007 15-May-07 25-Apr-07
Dealing with an Unsuitable
LAB 5B 2.0 29Sep2008 29-Sep-08
Sample
LAB 5D Corrective Action 2.0 29Sep2008 29-Sep-08
Maintenance and Monitoring
LAB 6A Lab Equipment Routine 2.0 30Apr2007 15-May-07 30-Apr-07
Maintenance
Appendix I - Equipment
Inventory template
Appendix III - prefilled with 30-Apr-07
current equipment 30Apr07
LAB 6D Handling Liquid Nitrogen 1.0 08Feb2006 9-Feb-06 8-Feb-06
Tank
LAB SOPs Page 10 of 17
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Version Number Kigali Effective Lusaka Effective Kitwe Effective Ndola Effective Date of Last
SOP Number SOP Title
and Date Date Date Date Date Review
Training and Safety
LAB 6E 2.0 28Apr2006 2-May-06 28-Apr-06
Fumigation (IAVI)
LAB 6F 2.0 29Sep2008 24-Oct-08
Waste Removal
Study Specific Schedule, Samples, and Assays
Sample Schedule for CVCT
LAB 7A 1.0 11May2006 16-May-06 11-May-06
and HT Studies
Amendment #1 to LAB SOP
3-Oct-06 17-May-07
7A
Study Specific Procurement, Storage, and Transport of Samples
LAB 8A 2.0 05Apr2007 6-Jun-07 5-Apr-07
Specimen Chain of Custody
and Sample Flow
Amendment #1 to LAB SOP 2.0 04Jun2007
8A
Amendment #2 to LAB SOP
2.0 27Jun2007
8A
Appendix 1: HT Labels
Template
Appendix 2: HT+Other
Study Labels Template
Appendix 6: CVCT
ELISA/p24 Tests and
Results Chain of Custody
Log Book
Appendix 7: RZHRG Sample
Procurement Log
Appendix 8: Transfer Log
V2.0
LAB SOPs Page 11 of 17
9fb1b313-9097-4eaf-b86e-b838c5166dfc.xls
Version Number Kigali Effective Lusaka Effective Kitwe Effective Ndola Effective Date of Last
SOP Number SOP Title
and Date Date Date Date Date Review
Training and Safety
Appendix 9: RZHRG Sample
Reception Log
Appendix 10: Copperbelt
Manifest
Appendix 11: RZHRG
Routine Lab Requisition and
Results Form
Appendix 12: RZHRG Non-
Routine Lab Requisition
Form
Appendix 13A: Volserum
2.0 Zambia
Appendix 13B: Volserum 2.0
Rwanda
Appendix 14: Preg-Trich-
Sperm Log
Appendix 15: SERUM Log
V2.0 – updated 14 Jun 2007
Appendix 16: Hematology
Log
Appendix 17: Medical Lab
Log V2.0
Appendix 18: RZHRG CD4
Log
LAB 8B Sample Labeling and Storage 2.0 14May2007 6-Jun-07 17-May-07
for HT Study
Amendment #1 to LAB 8B 5-Sep-07
LAB SOPs Page 12 of 17
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Version Number Kigali Effective Lusaka Effective Kitwe Effective Ndola Effective Date of Last
SOP Number SOP Title
and Date Date Date Date Date Review
Training and Safety
LAB 8D Collection, Preparation, and 1.0 19Apr2006 N/A 19-Apr-06
Storage of Dried Blood for
CB Sites (PIP)
LAB 8E Copperbelt Transportation of 1.0 15Dec2006 N/A 15-Dec-06
Specimens
LAB 8J 1.0 19Apr2006 19-Apr-06 19-Apr-06
Specimen Shipping (PIP)
LAB 8K (CL 8.3, 13.1) Specimen Shipping 3.0 01Aug2007 19-Sep-07 1-Aug-07
Clarification #1 to LAB 8K
3.0 22Aug2007
Ver 3.0
Laboratory Reagents
Use of Laboratory Reagents,
LAB 9A (IAVI 019.1) 2.0 30Apr2007 25-May-07 30-Apr-07
Expiry Dates and
Nomenclature
HIV Testing and Algorithm
LAB 11A 2.0 23Aug2006 24-Aug-06 23-Aug-06
HIV Testing Algorithm
LAB 11B Abbott Determine HIV- 2.0 08Sep2008 8-Sep-08
1/HIV-2 Rapid Test
LAB 11C Trinity Biotech Capillus HIV- 2.0 08Sep2008 8-Sep-08
1/HIV-2 Rapid Test
LAB 11D Trinity Biotech Uni-gold 2.0 08Sep2008 8-Sep-08
HIV-1/HIV-2 Rapid Test
LAB SOPs Page 13 of 17
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Version Number Kigali Effective Lusaka Effective Kitwe Effective Ndola Effective Date of Last
SOP Number SOP Title
and Date Date Date Date Date Review
Training and Safety
HIV Rapid Test – Use of
LAB 11F Whole Blood in Case of 2.0 08Sep2008 8-Sep-08
Power Failure
LAB 11G 1.0 23Apr2008 23-Apr-08
SD Bioline HIV ½ POCT 3.0
Elisa Checklist
HIV Elisas
LAB 12A BIORAD: Genetic Systems 1.0 13Dec2006 N/A 13-Dec-06
rLAV EIA
LAB 12B Abbott HIV ELISA Murex 1.0 06Mar2006 7-Jun-06 6-Mar-06
Ag/Ab Combination
LAB 12C Beckman Coulter p24 ELISA 1.0 01Mar2006 4-Jun-07 1-Mar-06
Antigen Test
LAB 12D Biorad Genetic System - HIV-1.0 04Jun 2007 12-Jun-07 4-Jun-07
1/HIV-2 Plus O EIA
Appendix IV: Reporting 1.0 04Jun2007
template
LAB 12E Vironostika HIV Uni-Form 2.0 13Dec2006 12-Jun-07 13-Dec-06
II Ag/Ab
Amendment #1 to LAB SOP
12E 23-Mar-07
Appendix III: Lusaka
template
Appendix IV: Kigali
template
LAB SOPs Page 14 of 17
9fb1b313-9097-4eaf-b86e-b838c5166dfc.xls
Version Number Kigali Effective Lusaka Effective Kitwe Effective Ndola Effective Date of Last
SOP Number SOP Title
and Date Date Date Date Date Review
Training and Safety
Panbio ELISA CHEK for
LAB 12F 1.0 01Oct2007 ……….. 1-Oct-07
ELISA Readers and Washers
Appendix 2: ELISA CHEK
17-Sep-07 17-Sep-07
spreadsheet template
HIV Seroconversion
LAB 13A HIV Seroconversion for 3.0 01Oct2007 7-Nov-07 1-Oct-07
RZHRG Studies
HSV Procedures and Assays
LAB 14A 2.0 25May2007 ………. 25-May-07
Focus HerpesSelect 2 IgG
Urine Pregnancy Testing
LAB 15A Hexagon hCG one-step 1.0 08Feb2006 N/A 8-Feb-06
Amendment #1 to LAB15A 5-Apr-07
Ver 1.0
LAB 15B Quickvue one-step hCG 1.0 08Feb2006 22-Jun-06 8-Feb-06
Urinalysis
LAB 16A Urinalysis 1.0 10Mar2006 17-May-06 10-Mar-06
Microscopy
LAB 17B Microscopic Examination of 2.0 17Sep2008 17-Sep-08
Endocervical and Vaginal
Swabs
LAB 17C Stool Examination 2.0 18Sep2008 18-Sep-08
LAB 17D Peripheral Blood Smears for 2.0 18Sep2008 18-Sep-08
the Detection of Malaria
Manual Differential
LAB 17E 2.0 18Sep2008 18-Sep-08
Counting of White Blood
Cells
Syphilis Testing
LAB SOPs Page 15 of 17
9fb1b313-9097-4eaf-b86e-b838c5166dfc.xls
Version Number Kigali Effective Lusaka Effective Kitwe Effective Ndola Effective Date of Last
SOP Number SOP Title
and Date Date Date Date Date Review
Training and Safety
LAB 18A Newmarket RPR Test 2.0 26Aug2008 26-Aug-08
LAB 18B BD MacroVue RPR Test 2.0 26Aug2008 26-Aug-08
LAB 18C HUMAN RPR Test 2.0 26Aug2008 26-Aug-08
LAB 18D SpinReact RPR Test 2.0 26Aug2008 26-Aug-08
LAB 18E Plasmatec RPR Test 2.0 26Aug2008 26-Aug-08
LAB 18F Omega TPHA 2.0 04Jun2007 N/A 4-Jun-07
LAB 18G Newmarket TPHA 2.0 30May2007 28-Sep-07 30-May-07
Axis-Shield Microsyph
LAB 18H 1.0 12Jun2007 12-Jun-07
TPHA
Chemistry
LAB 19A (IAVI SOP10) Clinical Chemistry testing 1.0 19Apr2006 19Arp2006 19-Apr-06
using the VITALAB Selectra
E clinical chemistry analyzer
Hematology
Hematocrit and ESR
LAB 20C 2.0 29Sep2008 29-Sep-08
Determination
Full Blood Count Using the
LAB 20D (IAVI SOP08A) 2.0 29Sep2008 29-Sep-08
Coulter A T 5diff
Hematology Analyzer
Handling Abnormal
LAB 20E 2.0 29Sep2008 29-Sep-08
Hematology Results
CD4/CD8 Assays
Becton Dickinson FACS
LAB 21A 2.0 23Oct2008 23-Oct-08
Count
DNA, Buffy Coats, White Cell Pellets
DNA Extraction Using
LAB 22A 2.0 06Oct2008 6-Oct-08
Qiagen Kit
LAB 22B Classic DNA Extraction 2.0 06Oct2008 6-Oct-08
Buffy Coat Collection and
LAB 22C 2.0 06Oct2008 6-Oct-08
Storage
LAB 22D White Cell Pellet Preparation 2.0 06Oct2008 6-Oct-08
LAB SOPs Page 16 of 17
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Version Number Kigali Effective Lusaka Effective Kitwe Effective Ndola Effective Date of Last
SOP Number SOP Title
and Date Date Date Date Date Review
Training and Safety Preparation and Storage of
LAB 22E Dried Blood Spots 2.0 22Aug2007 7-Nov-07 22-Aug-07
HBV and HCV EIA (Kigali Only)
Abbot Murex: HBsAg EIA
LAB 23A 1.0 18Jun2008 N/A N/A N/A 18-Jun-08
Version 3
Abbott Murex: anti-HCV
LAB 23B 1.0 18Jun2008 N/A N/A N/A 18-Jun-08
EIA Version 4.0
ELISPOT
Evaluation of Interferon-
LAB 24A (CL 4.4 03May05) gamma Producing Cells by 1.0 29Aug2007 29-Aug-07
ELISPOT Assay
Evaluation of ELISPOT
LAB 24B (CL 12.5
Numbers using an AID 1.0 29Aug2007 29-Aug-07
26Feb07)
Reader
PBMC
Isolation of Human PBMC
LAB 25A (CL 002.6) (IAVI) 2.0 11May2007 11-May-07
LAB 25B (CL 017.3) Use of Vi-cell counter for 3.0 15Aug2007 15-Aug-07
viable PBMC counting with
subsequent freezing
LAB 25C (CL 015.2) Haemocytometer counting 2.0 08May2007 8-May-07
and freezing human PMBC
LAB SOPs Page 17 of 17
