Following Good Clinical Practice
Good Clinical Practice (GCP) is in place to protect the rights, safety, and welfare of humans participating in research, and to assure the quality, reliability, and integrity of data collected. All members of the research team (investigators, sponsors, and Research Ethics Boards) are required to follow GCP.
It is strongly recommended that all non-regulated research studies maintain the documents below to comply with GCP guidelines. These documents are generally filed in the Trial Master File (sponsor), or the site regulatory file (site level). To assist you, the following list of required documents includes templates that can be used/modified for investigator-initiated and sponsored studies.
Download a listing of Essential Documents and their purposes here.
Suggested logs for clinical trials:
- Binder Tabs for the site regulatory file
- Screening Log
- Enrolment Log
- Delegation of Authority Log
- Training Logs
- Site IP Accountability Log
- Participant IP Accountability Log
- Temperature Log(s) A/B
- Protocol Deviation Log
- Monitoring Visit Log
- SAE Log and SAE Report Cover Sheet
Current CVs and practice licenses (as appropriate) should be maintained to show the qualifications of the study team.
Training and Standard Operating Procedures (SOPs) for Clinical Research Studies:
Most Research Ethics Boards (REBs) require that the course on research ethics be completed by all study team members, prior to receiving approval.
You must complete, at a minimum:
- GCP training. Note: In general, sponsors require re-training every two years (N2 offers a refresher course). Check with the institution you signed up with for their specific re-training requirements.
- If shipping specimens is included in your protocol, all personnel conducting the shipping must complete the Transportation of Dangerous Goods certification.
- Division 5 training (required for regulated studies)
- Responsible Conduct of Research (RCR)
Membership in N2 also provides access to a set of clinical research Standard Operating Procedures (SOPs) if your institution or research group do not have their own. Contact Erin Cherban or Leslie Love if you need access. At a minimum, you should have the following SOPs for a Health Canada-regulated clinical trial:
- Informed Consent Process
- Serious Adverse Drug Reaction Reporting
- Research Team Training
- Equipment Calibration and Maintenance
- Long Term Storage of Study Documents
- Management of Investigational Product (if applicable)
Trial Registration Requirements:
Any clinical study involving human participants must be registered on a public clinical trial registration website. The most commonly used is clinicaltrials.gov. Check with your local institution for information on registering your study. CTN can provide assistance with this service.
Defining Roles & Responsibilities:
If you are acting as sponsor-investigator for a multi-centre study, or you are receiving some support from an industry partner, document who is responsible for each study activity. This is often required when negotiating a contract with another institution. CTN requires a fully executed Roles and Responsibilities document be added as an addendum to the study contract.
You may wish to conduct a needs assessment in advance to determine your human resource requirements to perform the study (e.g. how much work will this study entail and what sort of training is required?). For Health Canada-regulated clinical trials, you are required to conduct this assessment prior to hiring staff.
You are legally obligated to ensure that both you and your staff have sufficient time to conduct the trial and that all personnel affiliated with the trial are sufficiently trained for their position.
We encourage investigators to contact the CTN’s Data Management group during protocol development, who can review the protocol and schedule of events, assist in building data collection instruments, identify critical data, review investigator responsibilities, discuss database design and platform, and determine timelines from protocol approval to end user training and database release.
Investigator input or approval is required at various stages of database development:
- Protocol Approval
- Data Collection Worksheets (DCWS) Approval
- Data Management Plan (DMP) Approval
- Online Review
- Database Release and User Request Approval
For details of Data Management Milestones, timelines, and team members involved, please download the document here.
A note about changes after the database has been released: The CTN has a robust Change Control procedure to ensure the integrity of our systems and data. Changes to a database following its release to production require a thorough justification, an impact assessment, and validation. Depending on the database, there may also be system limitations to consider. We endeavor to get things right the first time, with extensive review and approval of the database design before release.
Monitoring Plan and Statistical Analysis Plan (for multicentre studies):
For Health Canada-regulated clinical trials, you must provide oversight on the study to ensure it is conducted in accordance with the protocol, SOPs, GCP, and local requirements. Generally, this is completed by either onsite monitoring of study sites or remote monitoring through the data collected. The purpose of monitoring is to ensure the rights and wellbeing of participants are maintained, and that the data collected are accurate, complete, and verifiable from source documents (GCP 5.18.1). The extent and nature of monitoring will depend on the study. Contact Erin Cherban or Leslie Love if you need a monitoring plan template.
A Statistical Analysis Plan (SAP) is created before the research starts and defines the details of the planned statistical analysis. It usually includes sample tables, listings of data, and the manner in which the datasets will be analyzed. It usually lists methods for protocol deviations, unblinding, and how to deal with missing data. The SAP needs to be created by a statistician with experience in clinical trials.
Risk Management Plan:
The 2016 ICH E6 (R2) Addendum to Good Clinical Practice guideline requires clinical trial sponsors to incorporate a risk management plan. Risk Management allows the study team to identify areas where issues may occur, and incorporate strategies to prevent issues from impacting the study’s successful completion. For further information see Risk Management 101.
Think you are ready to start? Double-check using our Study Startup Checklist.