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Supporting Education and QI in Research (SEQuR)

GCP SOP's

1100

On SOPs: Preparing, Maintaining and Training

1100A

SOP Training Log

1100B

SOP Review Log

1101

Study Planning and Preparation

1101A

Protocol Assessment Checklist

1101B

Checklist of Activities for Pre-Study Qualification Visit

1101C

Pre-study/Qualification Visit Follow Up

1101D (1,2)

Study Training Log Version 1 and Version 2

1101E

Site Personnel Delegation of Responsibility

1101F

CRC Communication

1102

Interactions with the IRB

1103

Regulatory Files and Subject Records

1104

Study Monitoring Procedure

1104A

Accessing Charts Through Sunrise Clinical Manager and Sunrise Record Manager

1105

Study Closeout Procedure

1105A

NorDx Study Deletion Form

1105B

Study Closeout Checklist

1106

Investigational Drug/Device Accountability, Storage, Dispensing and Return

1106A

Sample Device Accountability Log

1106B

Sample Drug Accountability Log

1106C

Research Use of an Investigational Device-  Sign off Sheet

1106D

Operating Room Investigation Device Procedure

1107

Informed Consent Process

1107A

Guidance for Investigators- Obtaining Informed Consent

1108

Subject Recruitment

1108A

Email Notification- Research Subjects Admitted to the Hospital (Report Router)

1108B

Screening/Enrollment Log

1109

Subject Management While on Study

1109A

Guidance for Investigators -Study Subject Case History Documentation

1110

Reporting Adverse Events and Protocol Deviations/Violations and Unanticipated Problems

1110A

Adverse Event Log

1110B

Protocol Deviation Unanticipated Problem or Event Log

1111

Specimen Collection and Handling

1111A

NorDx Request for NorDx Support of Clinical Research Support

1111B

NorDx Laboratory Support for Clinical Research Study (Green Sheet)

1111C

Packaging "Biological Specimens, Category B"

1112

Data Management

1113

Audits

1113A

Preparing for an Audit Check List

1113B

Guidance for Investigators-Regulatory File- Essential Documents

1114

Transportation of Study Documents

Maine Medical Center Research Institute 81 Research Dr Scarborough, ME 04074 (207)396-8100

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