Personal Training Documentation[SH1]

Topic: Network of Networks (N2) Standard Operating Procedures (SOP)
SOP# / Version / Title[SH2]
002 / 07 / Research Team Roles and Responsibilities
003 / 07 / Research Team Training
004 / 07 / Clinical Research Protocol Feasibility and Site Selection
005 / 07 / Study Initiation/Activation
006 / 07 / Informed Consent Forms
007 / 07 / Research Ethics Board: Submissions and Ongoing Communication
008 / 07 / Informed Consent Process
009 / 07 / Subject Recruitment and Screening
010 / 07 / Management of Investigational Products
011 / 07 / Management of Biological Specimens
012 / 07 / Serious Adverse Drug Reaction Reporting in Clinical Trials
013 / 07 / Study Monitoring and Communication
014 / 07 / Clinical Data Management
015 / 07 / Investigator Study Files and Essential Documents
016 / 07 / Study Close-Out
017 / 07 / Audits and Inspections
018 / 07 / Clinical Trial Application (Drugs)
019 / 07 / Confidentiality and Privacy
023 / 03 / Clinical Trial Application (Natural Health Products)
024 / 03 / Investigational Testing Authorization (ITA) for Medical Devices (non-IVDD) and Manufacturer/Sponsor Obligations
025 / 03 / Equipment Calibration and Maintenance
Investigator Initiated and Electronic Data management SOPs
100 / 05 / CRF Design
101 / 05 / Study Analysis and Reporting
102 / 05 / Protocol Development
103 / 04 / Data Management Plan
104 / 04 / Database Set-up
105 / 04 / Database Maintenance and Management
106 / 04 / File Transfer
107 / 04 / Database Lock and Archiving
108 / 04 / System Set-up, Maintenance and Security
109 / 04 / System Backup and Recovery Planning

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 thelisted employee. The signature and date below is their attestation of completion of training. Training was overseen by______[SH3]

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Version 3

Employee

Signature: / Date:
(yyyy/mmm/dd)
Print Name:
Title:
Dept/Prog:

Trainer[SH4]

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 trainedon the Topic.

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.

[SH1]Instructions: Best practice is to have each research team member train on SOPs SOPs 2-19 & 25 for educational purposes.

Training on SOPs 23, 24, & 100-109 as applicable to each team member’s role/responsibilities or departmental requirements.

At a minimum, each team member must be trained on the SOPs that are consistent with their delegated tasks/study responsibilities.Ensure listing is revised to accurately reflect training received.

[SH2]Instructions: Review to ensure listing is complete and version # is accurate.

[SH3]Instructions: Insert name of trainer.

[SH4]The identified trainer/person authenticating training may be the Qualified Investigator (QI)/Principal Investigator (PI) or the Manager/Supervisor and must be a level higher than the research team member/employee.