Personal Training Documentation
Topic: Network of Networks (N2) Standard Operating Procedures (SOP)
SOP# Version
Title
002
Research Team Roles and Responsibilities
003
05
05
004
05
Clinical Research Protocol Feasibility and Site Selection
005
05
Study Initiation Activation
006
05
Informed Consent Forms
007
05
REB Submissions and Ongoing Communication
008
05
Informed Consent Process
009
05
Subject Recruitment and Screening
010
05
Management of Investigational Products
011
05
Management of Biological Specimens
012
05
SAR Reporting in Clinical Trials
013
05
Study Monitoring and Communication
014
05
Clinical Data Management
015
05
Investigator Study Files and Essential Documents
016
05
Study Close-Out
017
05
Audits and Inspections
018
05
Clinical Trial Application
019
05
Confidentiality and Privacy
023
01
Clinical Trial Application (Natural Health Products)
Investigational Testing Authorization (ITA) for Medical Devices
(non-IVDD) and Manufacturer/Sponsor Obligations
Equipment Calibration and Maintenance
024
025
01
01
Research Team Training
Investigator Initiated and Electronic Data management SOPs
100
03
CRF Design
101
03
Study Analysis and Reporting
Page 1 of 3
Version 2
102
03
Protocol Development
103
02
Data Management Plan
104
Database Setup
105
02
02
106
02
File Transfer
107
02
Database Lock and Archiving
108
02
System Setup Maintenance and Security
109
02
System Backup and Recovery
Database Maintenance
The trainer(s) listed below is/are available to answer your questions.
The above-named N2 SOPs and corresponding quiz questions have been reviewed and
understood by the listed employee. The signature and date below is their attestation of
completion of training. Training was overseen by _______________
Employee
Signature:
Date:
(yyyy/mmm/dd)
Print Name:
Title:
Dept/Prog:
Trainer
Signature:
Date*:
(yyyy/mmm/dd)
Print Name:
Title:
Dept/Prog:
*Denotes the date that the listed trainer has determined that the listed employee is
appropriately trained on the Topic.
Page 2 of 3
Version 2
NOTE: Trainer(s) to maintain all communications related to training (i.e. emails and
attachments, posters, etc.) to confirm the method of training, documents circulated for
review and duration of training, as applicable.