Guidance for clinical trials with decentralized elements: Conducting the trial, delegating activities
On this page
- Introduction
- Quality management systems
- Agreements
- Roles and responsibilities
- Delegating trial-related activities
- Routine procedures
- Training and qualification
- Delegation log
Introduction
Clinical trials that include decentralized elements may involve trial activities that take place away from the main clinical trial site, with the aid of digital health technologies and community-based health care resources. As per Division 5 of the Food and Drug Regulations (FDR), including sections C.05.010 to C.05.015, sponsors must ensure the trial is conducted in accordance with good clinical practices (GCP).
Access sections C.05.010 to C.05.015 of the FDR.
Quality management systems
Sponsors and qualified investigators (QIs) should work together with trial sites and service providers to implement a quality management system. Documented procedures (for example, standard operating procedures or SOPs and protocol procedures) help to ensure:
- quality at every stage of the trial process and at all sites
- that decentralized elements and activities have been appropriately integrated
- verifiable compliance with the regulations and the International Council for Harmonisation guideline ICH E6
From the outset, quality management activities should be reflected in the trial design and how it’s conducted. The focus should be on critical to quality factors.
Sponsors and QIs should implement appropriate processes to identify, evaluate, control, communicate and review risks that may affect participant safety or the reliability of trial results, including risks introduced by decentralized elements. Quality management systems should ensure that decentralized elements are planned, put into operation and overseen with the same rigor as activities conducted at traditional trial sites. This includes clear documentation of roles, responsibilities, communication pathways and data flows.
Sponsors are responsible for systems and procedures that ensure the quality of every aspect of the clinical trial and the reliability of the results. This includes responsibility for:
- monitoring and overseeing trial conduct at all locations, including remote locations, to ensure compliance with the protocol, GCP and applicable legal and regulatory requirements
- tailored to the identified potential safety risks, risks to data quality or reliability of the trial results and other risks related to decentralized elements
- focus on aspects that are critical to quality
- including third parties or contracted services involved in decentralized activities under documented quality expectations
- monitoring participant compliance with the therapy
- managing data and maintaining records from the trial to support compliance with regulatory and GCP requirements
- identifying, documenting, escalating and reporting adverse events in a timely manner to protect participant safety and as specified by the regulations, to minimize communication delays between the locations where trial activities occur and the main site
- disseminating critical information (for example, for the timely review of test results and participant monitoring), including information from remote assessments, local health care providers or digital platforms
- verifying validation and calibration of technical instruments and measuring devices used across decentralized locations, such as those used in delegated activities or by participants
- ensuring the integrity of the products is maintained when transported and stored to safeguard the safety of participants and address any potential risk of diversion of any controlled substance used in a trial
For information on safety reporting, including criteria and process, consult the section on serious unexpected adverse drug reaction reporting:
Agreements
Sponsors and QIs are responsible for ensuring that all agreements supporting decentralized trial activities clearly define the roles, responsibilities and oversight expectations of any delegated personnel, service providers or other third‑party organizations. Trial-related documentation should distinguish between activities that require agreements and those that fall within routine clinical, imaging or laboratory practice where delegation documentation or agreements may not be necessary.
Any of the sponsor’s or QI's trial-related activities that are delegated to and assumed by service providers should be documented in written agreements and the division of responsibilities defined. Clear, well-structured agreements help trial personnel, service providers and local health care providers comply with applicable laws, regulations and professional standards.
Agreements should establish how:
- trial‑related tasks will be performed, supervised and documented
- investigational drugs and data will be managed
- compliance with regulations and GCP will be maintained
Sponsors and QIs must ensure that all parties understand and adhere to the approved protocol, applicable regulatory requirements and any procedures necessary to protect participant safety, data integrity and privacy.
Agreements help ensure that individuals and organizations conducting trial-related activities:
- understand their responsibilities and liabilities
- support participant safety by incorporating appropriate risk mitigation measures
Written agreements, such as contracts, can clearly set out:
- individual roles and responsibilities, including who performs specific activities and where
- required qualifications (education, training and experience) for personnel conducting trial activities
- how specific trial activities will be conducted and monitored for compliance to the protocol
- professional liability among sponsors, QIs, sub-investigators and delegated third parties, including local health care providers
- procedures for safety monitoring and timely reporting of adverse events
- indemnity coverage for participants
- any considerations relevant to specific groups, communities and Indigenous communities
Records of agreements and contracts (paper or electronic) must be available or accessible from the main location of the clinical trial site. This includes any established contracts or agreements between the sponsor or QI and other third parties, institutions or locations that outline roles, responsibilities, liabilities and indemnities.
Health Canada may review these documents during an inspection to ensure that all:
- relevant activities are covered
- relevant parties are mentioned and audited
- agreements are complete
As per subsection C.05.012(4) of the FDR, records including agreements and contracts must be maintained for 15 years. It’s important to keep this documentation as it demonstrates who was responsible for specific trial activities, how oversight was maintained and how participant protection and data integrity were ensured.
We understand that clinical trials with decentralized elements may involve more service-provider agreements than traditional trial models. For this reason, we allow original paper documents to be converted into electronic copies for retention purposes (outlined in the GUI-0100 guidance).
For information on records access during inspection, consult:
For information on agreements, consult:
Other documents that may be relevant include:
- Tri-council policy statement: Ethical conduct for research involving humans
- Tri-agency research data management policy
Roles and responsibilities
Sponsors are responsible for the conduct of the clinical trial, while QIs are responsible for the conduct of the clinical trial at their site.
Both sponsors and QIs must ensure that all trial-related activities, including those in decentralized or remote locations, comply with applicable regulations, the approved protocol and ICH E6. This includes:
- appropriate oversight of all decentralized activities
- participant safety risks are managed
- drugs used in decentralized activities are transported, stored and handled according to good manufacturing practices (GMP) and the protocol
- all computerized systems and digital health technology supporting trial-related activities are validated, reliable and fit-for-purpose
- appropriate record-keeping and appropriate records retention for decentralized activities
- individuals and organizations performing trial-related activities are qualified by education, training and experience
Sponsor's obligations
Ultimately, sponsors are responsible for all trial-related activities, including any decentralized elements. This includes protecting participants’ rights, safety and well-being and ensuring the integrity and reliability of the trial data, in accordance with GCP and applicable regulatory requirements.
In general, sponsors are responsible for:
- oversight of the trial and regulatory compliance
- systems and procedures that assure the quality of every aspect of the clinical trial are implemented
- data handling, including the integrity and confidentiality of data
- recording, handling and storing all information related to a clinical trial in a way that allows complete and accurate reporting, interpretation and verification
- maintenance of records of personnel, activities and essential documents
- appropriate reporting and record-keeping of adverse events, including:
- suspected unexpected serious adverse reactions (SUSARs)
- serious adverse drug reactions (SADRs)
- serious unexpected adverse drug reactions (SUADRs)
- compliance with the approved protocol, investigational drug requirements and all applicable laws and regulatory requirements
- includes provincial or territorial statutes governing informed consent, privacy and health records management
For information on federal and provincial privacy laws, consult:
- Privacy Commissioner of Canada’s summary of privacy laws in Canada
- Provincial and territorial privacy laws and oversight
Qualified investigator responsibilities
In accordance with the interim policy for the modernization of the clinical trial framework (effective September 14, 2026)
Health Canada now allows a broader range of researchers to serve as QIs as long as medical decisions concerning the trial are made by a qualified physician or dentist on the clinical trial team.
The QI is responsible for the conduct of the trial at their site, any associated remote locations and any decentralized elements under their oversight. The QI must ensure the trial is conducted at their site in accordance with the approved protocol, applicable regulatory requirements and GCP, and that accurate and complete trial records are maintained.
In trials with decentralized elements, QIs may delegate trial-related activities to qualified personnel and third parties in accordance with applicable regulatory requirements and GCP.
While trial-related activities may be delegated, QIs are still accountable for participant safety, data reliability and compliance with applicable regulatory requirements.
Visit the section on delegating trial-related activities for other considerations related to delegation.
QIs should maintain appropriate oversight of trial conduct through a risk-based approach that is in proportion to the complexity of the activity and the associated risks to participant safety and data reliability. This includes ensuring appropriate operational and supervision plans are established and implemented for decentralized elements. Depending on the nature of the decentralized activities, QIs may also need to determine how to integrate those activities with local health care systems, telehealth platforms, institutional policies and training requirements.
Oversight responsibilities may include:
- ensuring timely access to trial-related medical care and medical decision-making, even in decentralized locations
- maintaining accountability for the investigational product, even in decentralized locations
- ensuring validation and calibration of technical instruments and measuring devices used at the trial site, associated locations, delegated activity locations or by participants
- monitoring data quality, reliability and fit-for purpose throughout the trial
- supporting monitoring, audits and inspections by maintaining access to essential documents and addressing identified issues or deviations
Delegating trial-related activities
Trial-related activities may be delegated to third parties, including service and local health care providers, when delegation supports the conduct of the clinical trial. These delegated activities may range from highly specialized procedures requiring specific equipment, expertise or training to tasks that fall within the standard scope of practice of local providers.
Sponsors may transfer or contract trial-related responsibilities and activities to qualified third parties, such as contract research organizations (CROs), laboratories and service providers. However, sponsors retain responsibility for ensuring appropriate oversight of trial-related activities that are transferred or contracted to third parties.
QIs may also delegate trial-related activities to qualified:
- trial personnel
- third parties, such as
- health care providers
- health centres or clinics
- contracted service providers
When delegating activities, QIs must ensure that delegated activities are conducted in accordance with the approved protocol, applicable regulatory requirements and GCP. They must also ensure that delegated individuals and organizations have the necessary education, training, experience, qualifications and resources to perform their assigned responsibilities safely and in compliance with the protocol and regulatory requirements.
QIs are accountable for all trial-related activities conducted under their authority, including activities delegated to trial personnel or third parties. They should maintain appropriate oversight to protect the rights, safety and well-being of trial participants and ensure the reliability of trial data.
Regulations do not stipulate which clinical trial activities may or may not be delegated, or what specific training must be completed for each delegated activity. Rather, QIs are responsible for ensuring that delegated activities are performed competently and in compliance with the protocol, applicable regulations and GCP. Delegation should be clearly documented and consistent with the principles of ICH E6. Oversight should be in proportion to the complexity of the trial and the associated risks to participant safety, data reliability and other critical to quality factors.
As QIs oversee delegated activities throughout the trial, they should implement procedures to help them:
- identify and manage risks to critical to quality factors
- supervise delegated activities in accordance with documented operational and supervision plans
- may include, for example, holding regularly scheduled supervision meetings or reviewing delegated activities
- ensure data security and integrity at a main site and related locations
- ensure appropriate record-keeping for trial-related documents (paper or electronic), including delegation logs, agreements and other relevant documentation
- make all trial-related records available at the QI’s main clinical trial site
- ensure access to and management of essential records throughout the trial and their retention after the trial has ended
For information on documenting delegated activities, consult the section on good clinical practices:
Routine procedures
In general, routine clinical procedures (for example, routine blood tests or medical imaging, or standard-of-care procedures performed by local health providers) don’t require specific trial-related training and delegation from a QI. However, where feasible, the QI should confirm that the individuals performing these procedures are qualified. This may mean verifying appropriate licensing or certification by applicable health authorities.
Trial-related documentation can be used to distinguish between activities that require delegation and trial-specific training, and those that fall within routine clinical practice, where such documentation or training may not be necessary. Documentation on the qualifications of third parties involved in routine procedures may not always be requested during an inspection.
Training and qualification
Any personnel or third parties involved in trial‑related activities should have the necessary education, training, experience and resources to carry out their responsibilities in accordance with the protocol and regulatory requirements.
Sponsors and QIs should identify and document the specific training required for the activity to be conducted by delegated personnel or third parties.
For example, activities may include procedures that:
- require specific knowledge of the trial protocol, investigational drug, investigator's brochure or the specific disease area under study
- fall within the standard scope of practice of the applicable health care provider without additional training
For these activities, it may be crucial for delegated personnel or third parties to be aware of:
- participant safety (such as identifying possible adverse events)
- principles of ongoing consent
- protocol deviation reporting
- privacy breach reporting
- escalation pathways
Training requirements should be flexible to minimize unnecessary burden for participating health care providers while ensuring that delegated activities are conducted safely and according to the protocol, applicable regulations and GCP. Training should be appropriate to the delegated activity, as not everyone in the delegation log is required to have the exact same trial-specific training.
In general, training should include the relevant sections of trial protocol for which the person is responsible. If applicable to the duties being delegated, training could also be provided on relevant supporting guidance, including, for example, ICH E6, or on the specific medical condition under study.
For information on training, consult:
Delegation log
QIs should ensure a record is maintained of the persons and parties to whom the investigator has delegated trial-related activities (delegation log). Trial-specific tasks should not be conducted until the QI has documented the delegation and appropriate training has been completed.
The delegation log should be:
- completed before the trial begins and updated as necessary
- legible, adequately completed and clearly identify the names and signatures of key personnel, their key duties and the start and end dates of those duties
- signed and dated by the QI before a task has been delegated
Documentation of delegation should be in proportion to the significance of the trial-related activities. If activities are performed as part of standard-of-care clinical practice or by unplanned urgent care providers, delegation documentation or inclusion in the delegation log isn’t usually required. As well, when tasks are delegated to a person in charge of other staff, further sub-delegation to individual staff doesn’t need to be documented in the log, provided that evidence of their qualifications is available.
The delegation log and other relevant documentation to manage delegated activities must be available at the main location of a clinical trial site. We may request this information during an inspection.
For information on delegation logs, including examples of delegated duties to be captured, consult: