# Quality Assurance for Clinical Trials

**Source**: https://cumming.ucalgary.ca/research/cccr/clinical-trials-office/quality-assurance-clinical-trials
**Parent**: https://cumming.ucalgary.ca/

The CCCR provides Quality Assurance (QA) and Regulatory Compliance services for the research community to ensure that all clinical research meets high-quality standards and ICH *Guideline for Good Clinical Practice*and applicable regulations are followed in the conduct of clinical trials. The QA program conducts internal file Reviews which verify that research studies are conducted and data is generated, documented and recorded in compliance with the study protocol, applicable regulations, standard operating procedures and institutional policies.

The University of Calgary (through its membership with N2) provides access to CITI’s online training as well as access to their complete set of Clinical Research Standard Operating Procedures (SOPs). The QA program also supports the research community by providing standard tools and processes.

For additional information about QA and Regulatory Compliance services, please [contact our office](https://cumming.ucalgary.ca/dev/research/cccr/contact).

## Resources

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#### Tools & Templates

[Go](https://cumming.ucalgary.ca/research/cccr/clinical-trials-office/quality-assurance-clinical-trials/tools-and-templates)

#### Standard Operating Procedures (SOPs)

[Go](https://cumming.ucalgary.ca/research/cccr/clinical-trials-office/quality-assurance-clinical-trials/standard-operating-procedures)

#### Training & Education

[Go](https://cumming.ucalgary.ca/dev/research/cccr/clinical-trials-office/quality-assurance-clinical-trials/training-and-education)

#### Regulations, Guidelines and Important Links

[Go](https://cumming.ucalgary.ca/dev/research/cccr/clinical-trials-office/quality-assurance-clinical-trials/regulations-guidelines-important)

#### Network of Networks

[Go](https://cumming.ucalgary.ca/dev/research/cccr/clinical-trials-office/quality-assurance-clinical-trials/n2-canada-network-networks)

## Memo archive

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#### October 17, 2025

[Health Canada implementation of the ICH E6(R3) guideline](https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/implementation-ich-e6r3-guideline-notice.html)

#### September 11, 2025

[E6 (R3) Transition Training](https://cumming.ucalgary.ca/sites/default/files/teams/27/E6(R3)%20Training%20Requirement%20Memo%20Update%20Feb%202026.pdf)

#### April 30, 2025

[FDA Form 1572 Policy](https://cumming.ucalgary.ca/sites/default/files/teams/27/UCalgary%20policy-on-form-1572.pdf)

#### June 13, 2023

[Release of Version 10 N2SOPs](https://uofc-my.sharepoint.com/:b:/g/personal/jade_andersen_ucalgary_ca/Eb4OTLWdROZAlf1fV_ohDT8BKtIz2mc5fjfFl2SoSwmQgg?e=mcde2m)

#### February 2023

[New Requirements for the Provision of Psychedelic Drugs in Alberta](https://cumming.ucalgary.ca/sites/default/files/teams/27/Letter%20to%20Health%20Ethics%20Boards%20February%202023.pdf)

#### April 19, 2022

[CCCR Record Retention Rule 2011.01 Announcement](https://cumming.ucalgary.ca/sites/default/files/teams/27/CCCR%20Clinical%20Research%20Update%20-%20Retention%20Rule%202011.01%20-%20April%2C%202022.pdf)

#### May 27, 2020

[Clinical Trials Monitoring and Study Status Update - COVID-19](https://research.ucalgary.ca/sites/default/files/RSO%20Docs/Quality%20Assurance/COVID-19_Clinical_Trials_%20Monitoring_and_Study_Status%20Updates_27_May_2020.pdf)

#### April 4, 2019

[Release of ICH E6(R2): Good Clinical Practice](https://research.ucalgary.ca/sites/default/files/RSO%20Docs/Quality%20Assurance/%5BClinical-coordinators-l%5D%20Notice%20%E2%80%93%20Release%20of%20ICH%20E6(R2)_%20Good%20Clinical%20Practice.pdf)

#### October 23, 2018

[CCCR News: TRW Research Pharmacy noon closure starting Dec. 3, 2018](https://ucalgary.ca/research/files/research/cccr-news_-trw-research-pharmacy-noon-closure-starting-december-3rd-2018.pdf)

#### August 15 , 2023

[Monitor/ Auditor Access to AHS Patient Records](https://cumming.ucalgary.ca/sites/default/files/teams/27/Auditor%20Monitor%20Access%20to%20AHS%20Patient%20Records%20July%202023.pdf)

#### October 12, 2018

[Health Canada Announces ITA changes](https://cumming.ucalgary.ca/sites/default/files/teams/27/cccr-news_-health-canada-announces-changes-to-medical-device-trial-approval-process.pdf)

#### April 20, 2018

[Mandatory CITI Training](https://ucalgary.ca/research/files/research/mandatory-gcp-and-div-5-training-requirements.pdf)

#### October 17, 2017

[Mandatory TCPS 2 training](https://ucalgary.ca/research/files/research/mandatory-human-research-ethics-training.pdf)

#### July 5, 2023

[Good clinical practice (ISO14155)](https://cumming.ucalgary.ca/sites/default/files/teams/27/ISO14155%20Clinical%20investigation%20of%20medical%20devices%20for%20human%20subjects%20good%20clinical%20practice%20(1).pdf)

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## Questions?

For regulatory questions related to your trial, please contact**Jenna****Dobry.**

### Jenna Dobry, BSc, MSL | Quality Assurance and Regulatory Compliance Specialist

**Email:** [**jldobry@ucalgary.ca**](https://cumming.ucalgary.ca/research/cccr/clinical-trials-office/jldobry@ucalgary.ca)

**Teams: [jldobry@ucalgary.ca](https://cumming.ucalgary.ca/research/cccr/clinical-trials-office/jldobry@ucalgary.ca)**