Attch11USAMRDCORASOP.xlsx
XLSX spreadsheet 14 KB Posted
- Solicitation number
- W81XWH21R0078
- Issued by
-
Department of the Army Medical Command
About this file
This government file contains standard operating procedures (SOPs) for the U.S. Army Medical Research and Development Command (USAMRDC) Office of Regulated Activities (ORA). The SOPs relate to clinical research support services including protocol development and review, clinical trial monitoring, safety surveillance, regulatory submissions and interactions, quality assurance, and product accountability. Also included are templates for various documents used in clinical research operations and regulatory processes.
The related federal contract opportunity is a solicitation seeking proposals for regulated activities support services to be provided to the USAMRDC ORA. Services will include clinical research support, quality management, regulatory compliance, data management, and product oversight. The single-award indefinite delivery/indefinite quantity contract has a one-year base period and four one-year options, for a total of five years. Proposals are due by April 23, 2021. The estimated value is $50 million. The solicitation is designated as a small business set-aside.
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Text version
Sheet1
| MRDC ORA SOPS |
| SOP.6.03.F07 PTO Site Visit Agenda Letter Template - Civilian |
| SOP.6.03.F05 PTO Site Visit Report Cover Letter Template - Civilian |
| SOP.6.03.F03 PTO Site Response Letter Template � MILITARY |
| SOP.6.04.F01 PTO Product Testing Summary |
| SOP.6.03.F06 PTO Site Visit Response Letter Template - Civilian |
| SOP.5.03.F02 SADE_UADE_SAE Report Form and Guidelines |
| SOP.5.01.F05 Narrative Sample Template and Guideline |
| SOP.5.01.F03 Phone Contact Report Form |
| SOP.5.04.F02 DSMB Charter |
| SOP.5.04.F05 Sponsor Rec Memo |
| SOP.5.04.F01 DSMB Conflict of Interest Statement |
| SOP.6.05.F02 GLP Report Checklist |
| SOP.6.05.F01 GLP Study Protocol Checklist |
| SOP.9.01.F03 Inspection Report |
| Internal Audit Schedule Template |
| SOP.2.01.F02 Site Qual_Pre-Study Monitoring Visit Summary.pdf |
| SOP.2.01 Preparation Routing and Dist of CMR and CAR (v01).pdf |
| SOP.7.17 Annual Report Preparation (v01).pdf |
| SOP.2.02 Clinical Trial Monitoring_Preparation for Monitoring Visit (v01).pdf |
| SOP.8.07 Submission Quality Review (v00).pdf |
| SOP.2.06 Clinical Trial Monitoring_Close-Out Monitoring Visit (v01).pdf |
| SOP.6.02.F03 Inventory Destruction Confirmation Form.pdf |
| SOP.8.01 Submission, Mgmt, and Retrieval of the Sponsors Regulatory Files (v01).pdf |
| SOP.6.02 PTO IP Accountability (v00).pdf |
| SOP.6.02.F01 Inventory Transfer Request Form.pdf |
| SOP.6.02.F02 Destruction Request Form.pdf |
| SOP.9.13 Enclosure 1 Reg Proj Bus Process Flow 06MAR2020.pdf |
| SOP.9.13 Regulatory Project Business Process (v00).pdf |
| SOP.9.12 Risk Identification, Management, and Reporting.pdf |
| SOP.9.07.F04 Documentation of Review Form for SOPs Forms WIs (v01) |
| SOP.9.07 Document Control System for Standard Operating Procedures Form (v01) |
| SOP.9.07.F03 Document Control Request Form (v01) |
| SOP.2.09 CRA Protocol Training (v00).pdf |
| SOP.7.11.F01 FDA Communication Record.pdf |
| SOP.7.11 Documentation of Informal Communications with FDA (v01).pdf |
| SOP.5.05 Sponsor Reg Review and Approval for TSG-DA sponsored prots (v00) |
| SOP.5.05.F02 PRB Meeting Agenda Minutes |
| SOP.5.05.F01 PRB_Comment__Matrix |
| SOP.5.05.F03 PRB Consolidated Comments |
| SOP.5.05.F04 Protocol Package Requirements List |
| SOP.6.03 PTO Site Visit and Report Writing.pdf |
| SOP.6.04 PTO Oversight of Product Testing (v00) |
| Product Technical Operations �Site Visit and Report Writing |
| SOP.5.03.F04 PSSB Training Log |
| SOP.5.03 PSSB Project Implementation and Termination (v00) |
| SOP.2.10 Study Close-out (v00) |
| SOP.2.10.F01 Sponsors Clinical Study Close-Out Checklist |
| SOP.5.01 Invest Product Safety Event Processing and Preparation of Exped |
| SOP.1.01.F02 ORA Biostatistical_Close Out |
| SOP.1.01 Good Statistical Practice in Clinical Research (v00) |
| SOP.1.01.W01 Biostatistics Regulatory Oversight |
| SOP.1.01.F01 ORA Biostatistical_Study Start |
| SOP.8.05 Steps for Building a Submission in the Electronic Document Management System (EDMS) (v00) |
| SOP.5.02 Use of Safety Surveillance Database for FDA-Regulated Clinical Trials (v00) |
| SOP.5.02.W01 Argus Data Entry Guidelines |
| SOP.3.01 Conduct of Data Management Activities (v00) |
| SOP.5.04 Implementation and Management of a DSMB (v00) |
| SOP.6.01 Technical Review of Documents (v00) |
| SOP.6.05 GLP Study Protocols and Reports (v00) |
| SOP.2.07 Contracted Monitor Surveillance (v00) |
| SOP.7.10 Reg of Submitting Results on ClinicalTrials dot (v00).pdf |
| SOP.6.06 Review and Oversight of Product Stability |
| SOP.7.14 Requesting an application number for eCTD from CDER |
| SOP.7.13 Requesting an application number for eCTD from CBER |
| SOP.8.02 Use of Sponsor External Archives (v00) |
| SOP.2.04 Clinical Trial Monitoring - Site Initiation Visit (v00) |
| SOP.2.11 Sponsors Clinical Study Start Checklist (v00) |
| SOP.2.11.F01 Sponsors Study Start Checklist (v00) |
| SOP.7.03 IND Inactivation or Withdraw (v00) |
| SOP.7.04 Preparation-Content-Submission of Protocol Amendments (v00) |
| SOP.7.15 TORO Document Development Review and Approval Process (v00) |
| SOP.7.16 Sponsor's Cross Reference Authorization (v00) |
| SOP.9.01 Mnmgt of Ext Inspections Performed at Office of Regulated Activities (v00) |
| SOP.7.07 Preparation of Drug and Biologic Master Files (v00) |
| SOP.7.08 Amendmnt Prep and Submission for Drug and Biologic Master Files (v00) |
| SOP.8.01 Submission, Mgmt, and Retrieval of the Sponsor_s Regulatory Files (v00) |
| SOP.7.05 Preparation-Content-Submission of Information Amendements (v00) |
| SOP.2.05 Clinical Trial Monitoring - Interim Monitoring Visit (v00) |
| SOP.8.01.W02 Guide to Decrypting Winzip Files Sent via Email |
| SOP.8.01.W01 Guide to Encrypting Files with WinZip and Sending Them via Email |
| SOP.8.04 Regulatory Submissions Process (v00) |
| SOP.8.06 Procedure for Assigning Sponsor Study Numbers (v00) |
| SOP.2.08 Clinical Monitoring Plan Development (v00) |
| Monitoring Visit Preparation Checklist |
| SOP.2.03 Clinical Trial Monitoring - Site Qualification Visit (v00) |
| SOP.2.03.F01 Qualification-PreStudy Meeting Agenda (v00) |
| SOP.7.06 Procedure for Responding to a Clinical Hold (v00) |
| SOP.7.12 Meeting with the Food and Drug Administration (00) |
| SOP.9.03 Corrective Action / Preventive Action (CAPA) Process (v00) |
| External Audit Procedure |
| Internal Audit Procedure |
| Product Technical Operations � Site Visit Agenda Letter Template - Civilian |
| Product Technical Operations � Product Stability Summary |
| Sponsor Regulatory Review and Approval for The Surgeon General, Department of the Army (TSG-DA)-Sponsored Products |
| Product Safety Surveillance Branch Project Implementation and Termination |
| Protocol-Specific Training and Documentation for Clinical Trial Monitors |
| Product Technical Operations - Oversight of Product Testing |
| Sponsor�s Clinical Study Close-Out Checklist |
| Procedure for Response to Request forExpanded Access IND |
| Product Technical Operations � Site Visit Response Letter Template - Civilian |
| PAO Destruction Memorandum � Civilian |
| Investigational Product Safety Event Processing and Preparation of Expedited Safety Reports for FDA-Regulated Clinical Trials |
| Product Technical Operations � Site Visit Response Cover Letter Template - Civilian |
| Product Accountability Oversight Release and Distribution/Destruction Authorization Memoranda |
| Clinical Study Report Preparation and Review |
| Protocol Package Requirements List |
| Destruction Request Form |
| Serious Adverse Event (SAE)/Events of Special Interest Report |
| Good Statistical Practice in Clinical Research |
| PAO Product Destruction Memo � MILITARY |
| Sponsor�s Clinical Study Implementation Authorization Procedure |
| PSSB Training Log |
| USAMMDA Managers' Internal Control Plan |
| Product Technical Operations �Site Visit and Report Writing |
| PAO Release and Disposition Memorandum � Civilian |
| SADE/UADE and SAE Report Form |
| Protocol Specific Training for Clinical Trial Monitor |
| Product Technical Operations � Site Visit Report Cover Letter Template (MILITARY) |
| TEMPLATE: MEMORANDUM: Protocol Review Board (PRB) Protocol Package Review |
| Creating and Using Form FDA 3514 |
| Research Monitor Report |
| Template: Protocol Review Board (PRB) Meeting Agenda |
| Product Technical Operations � Product Testing Summary |
| Clinical Services Support Division PSSB Specific Training |
| Emergency Use Compliance Checklist |
| Creating and Using Form FDA 2252 |
| Formatting Submission Documents |
| Creating and Using Form FDA 356h |
| Product Technical Operations � Site Visit Agenda - Military |
| Template: E-mail Scripts: Notification of Protocol Review Board (PRB) Protocol Package Review |
| Pregnancy Report Form |
| Creating and Using Form FDA 1571 |
| Product Accountability Oversight (PAO) Checklist |
| Product Shipping/Transfer and Receipt Log |
| PAO Product Release and Disposition Memo � MILITARY |
| Temperature Monitoring Devices Sign-Out, Return and Data Retrieval, and Re-Order Procedure |
| Inventory Destruction Confirmation Form |
| Request for Destruction of Hard-copy Regulatory Documents |
| Creating and Formatting Cover Letters for Electronic and Paper Submissions |
| Product Technical Operations � Site Response Letter Template - Military |
| Biostatistics Regulatory Oversight |
| Blinding and Unblinding of Clinical Trials |
| TEMPLATE: Serious Adverse Event (SAE) Report Form |
| Analysis of Similar Events Template and Guidelines |
| Tracking of Study Start-Up Tasks |
| Creating and Using Form FDA 3674 |
| Template: E-mail Scripts: Confirmation Receipt: Protocol Package Received for Protocol ReviewBoard (PRB) Review |
| Safety Management Plan |
| SAE Follow-up Request Form |
| Template: Protocol Review Board (PRB) Comment Matrix |
| Inventory Transfer Request Form |
| Product Technical Operations Responsibilities for Investigational Product Accountability |
| Narrative Sample Template and Guidelines |
| Sponsor's Clinical Study Close-Out Checklist |
| Documentation of Facsimile and US Mail Communications from FDA |
| FDA Communication Record |
| Clinical Monitoring Visit � Monitoring Equipment Checklist |
| Emergency Use Contact List |
| Clinical Trial Monitoring � Site Review Preparation Checklist |
| Phone Contact Report Form |
| Sponsor�s Clinical Study Implementation Authorization Letter (Civilian) |
| SOP.2.01.F04 Initiation Monitoring Visit Summary.docx |
| SOP.2.01.F06 Close-Out Monitoring Visit Summary.docx |
| SOP.2.01.F03 Monitoring Report Letter Template to Military Address.docx |
| SOP.2.01.F05 Interim Monitoring Visit Summary.docx |
| SOP.2.01.F01 Monitoring Report Cover Letter to Civilian Address.docx |
| SOP.2.02.F01 Monitoring Visit Preparation Checklist.docx |
| SOP.2.02.F03 Clinical Monitoring Visit - Monitoring Equipment Checklist.docx |
| SOP.2.02.F02 Clinical Monitoring Visit - Site Review Preparation Checklist.docx |
| SOP.9.13 Enclosure 2 Regulatory Support Questions.docx |
| SOP.9.12.F01 Risk Register ORA 20200331.XLSX |
| SOP.9.07.F02 Work Instruction Template |
| SOP.9.07.F01 SOP Template |
| SOP.2.09.F01 Protocol Specific Training for Clinical Trial Monitor (v00).docx |
| SOP.6.03.F04 PTO Site Visit Agenda Letter Template � MILITARY |
| SOP.6.03.F01 PTO Site Visit Cover Letter Template - MILITARY |
| SOP.6.03.F02 PTO Site Visit Report Template |
| SOP.6.04.F02 PTO Product Stability Summary |
| SOP.5.03.F03 Safety Management Plan |
| SOP.5.03.F01 Pregnancy Report Form |
| SOP.5.01.F06 Research Monitor Report Form (v00) |
| SOP.5.01.F04 Analysis of Similar Events Template and Guidelines |
| SOP.5.01.F07 SAE EOSI Report Form (v00) |
| SOP.5.01.F01 SAE Report Form |
| SOP.5.01.F02 AE Follow-up Request Form |
| SOP.1.01.F03 Early Phase Clinical Development Plan (Vaccine Example) |
| SOP.3.01.F15 Database Unlock Checklist |
| SOP.3.01.F13 QC Approval Checklist |
| SOP.3.01.F08 eCRF Data Entry Guidelines Template.pdf |
| SOP.3.01.F04 Database Specifications Template |
| SOP.3.01.F05 Database Testing Finding Summary Template |
| SOP.3.01.F01 Sample CRF Template |
| SOP.3.01.F17 Data Transfer Plan Template |
| SOP.3.01.F06 Database Release to Production Checklist |
| SOP.3.01.F07 Database Access Control Form |
| SOP.3.01.F12 Database CCR Form |
| SOP.3.01.F18 Data Transfer Log |
| SOP.3.01.F03 DVP Template |
| SOP.3.01.F11 SAE Reconciliation Approval Checklist |
| SOP.3.01.F14 Database Lock Checklist |
| SOP.3.01.F02 DMP Template |
| SOP.3.01.F10 Medical Coding Approval Checklist |
| SOP.3.01.F16 Data Management Deliverable Checklist |
| SOP.3.01.F09 DCF Template |
| SOP.5.04.F06 CommPlan |
| SOP.5.04.F04 Site notification Establishment of a Clinicatl Trial DSMB final |
| SOP.5.04.F03 PI Notifi DSMB Recommn_Sponsor Determn |
| SOP.6.01.F01 PTO Document Review Form |
| SOP.2.07.F02 Oversight Monitoring Tracking Form |
| SOP.2.07.F05 Interim Co-Monitoring Visit or Sponsor Only Visit Report |
| SOP.2.07.F06 Close-out Co-Monitoring Visit Report |
| SOP.2.07.F04 Site Initiation Co-Monitoring Visit Report |
| SOP.2.07.F01 Oversight CMP Template |
| SOP.2.07.F07 Pre-Study Co-Monitoring Visit Report |
| SOP.2.08.F01 Clin Monitoring Plan Template |
| SOP.2.07.F03 Site Qualification Co-Monitoring Visit Report |
| SOP.7.15.F02 TORO Document Template |
| SOP.2.04.F01 Site Initiation Monitoring Visit Meeting Agenda |
| SOP.7.15.F01 TORO Determination Assessment Checklist |
| SOP.9.01.F01 Daily Inspection Report.docx |
| SOP.9.01.F02 Document Request List.docx |
| Internal Audit Form |
| External Audit Report Memorandum Template |
| Internal Audit Plan Memorandum |
| Internal Audit Report |
| SOP.9.03.F02 Corrective Action Preventive Action Form |
| SOP.9.03.F04 Monthly CAPA Status Report to Management |
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