SOP for Site Staff Qualifications, Training Records and Capability

Purpose

The purpose of this Standard Operating Procedure (SOP) is:

• to ensure the appropriate documentation of clinical research site staff qualifications and training records are completed and maintained up to date during the course of the study, and
• to ensure the provision of resources to perform clinical research at all clinical research sites, according to the principles of the ICH GCP, the National Statement (or its successor), and the requirements of the Clinical Trials Governance Framework.

Scope

This SOP applies to all relevant employees including, but not limited to, visiting health professionals, contractors, consultants and volunteers who propose to undertake, administrate, review and/or govern human research involving patients/participants and staff. All study personnel involved in the clinical study must operate within their scope of practice.

Procedure

1. Site Staff Qualifications

The Principal Investigator must:

• Be qualified by education, training and experience, including in skills, competencies and training requirements articulated in the National Clinical Trials Governance Framework, to assume ultimate responsibility for the proper conduct of the research.
• If required by the local site RGO, submit a current Curriculum Vitae (CV) to the RGO if not submitted previously and at any time the CV changes including;

1. current Regulation Agency registration details
2. evidence of appropriate GCP training
3. other relevant documentation requested by the Sponsor, the HREC, and/or the regulatory authority.
4. current workplace name and address.

• Ensure all investigational site staff, at both Primary and Satellite Sites, or independent third parties, and external service providers have provided appropriate and current evidence that they are qualified by education, training and experience, including in skills, competencies and training requirements articulated in the National Clinical Trials Governance Framework, to assume responsibilities to perform the delegated study-related duties and functions and that they have the legal authority to do so. Delegation should be consistent with the Roles and Responsibilities specified in the Clinical Trials Governance Framework.
• Ensure all investigational site staff, at both Primary and Satellite Sites, independent third parties and/or external service providers, who have been delegated significant responsibilities have a current CV lodged with the research office/SMF for sighting by the Sponsor and/or regulatory authority.
• Implement procedures to ensure the delegated study-related duties and functions are carried out safely.
• Implement procedures to ensure integrity of all data generated.

2. Site Staff Training Records

The Principal Investigator must:

• Ensure all required staff, including new staff involved during the course of a study, who assist with the clinical trial are informed about and trained on the Protocol, any Investigational Product, and their research-related duties and functions. This can be in the form of an Initiation meeting held by any communication means e.g. via face-to-face, video conference etc.
• Ensure that for all study specific training provided, there is a record of documents and tools used, including details of who provided the training and when it was provided, by trial specific staff.
• Ensure all required training is completed and the training record is kept up to date. A copy must be kept at the Primary Site and/or Satellite Sites (when applicable) and available for review on request throughout the entire duration of the clinical research trial.

ALSO READ: SOP for Responsibilities of the Research Team

3. Capability

The Principal Investigator must:

• When a teletrial is being conducted, the PI, who is always at the Primary Site and never at the Satellite Site, remains responsible for the trial across the cluster.
• Undertake the roles and functions of the Site Principal Investigator specified in the Clinical Trials Governance Framework.
• Demonstrate the potential for recruiting the required number of suitable participants, either from the Primary Site only, or from the Primary Site and associated Satellite Sites, within the specified recruitment period. This may be in the form of de-identified participant recruitment listings or other documented written or printed evidence.
• Have sufficient time to properly conduct and complete the research within the specified period.
• Have an adequate number of qualified staff and adequate facilities for the foreseen duration of the research.
• Ensure that a robust site assessment is undertaken that fully quantifies the capabilities of each Satellite Site to inform the extent to which trial related activities can be delegated to the site. This may include a pre-commencement assessment before a specific trial is proposed so that the process of trial start up is expedited when a suitable trial is identified. For Satellite Sites that have no or limited experience in delivering clinical trials, a staged approach may be undertaken to allow for gradual building of clinical trials capacity and capability (e.g. the Satellite Site is initially involved in less complex trials with greater levels of oversight provided by the Primary Site).
• Maintain a record identifying appropriately qualified persons to whom they have delegated significant research-related duties (on a ‘per person’ basis) such as a Delegation Log.

1. Staff who as part of routine practice provide ancillary or intermittent care by completing a procedure on a trial patient/participant (i.e. vital signs, electrocardiography (ECG), venepuncture or imaging) generally do not need to sign a Delegation Log (or be listed on a 1572 Form for trials conducted under an Investigational Drug Investigation). However, if a key trial end point is based on reporting from routine care, then this should be clearly reflected in the Delegation Log as in this context, such reporting is considered critical to the trial.
2. Where service departments (e.g. pharmacy, laboratories, radiology) are involved in trial-specific activities (e.g. dispensing Investigational Medicinal Products), the PI may delegate the role of supervising and training departmental staff to a Named Person (e.g. a clinical trial pharmacist). This person would train all staff on any aspects of GCP/the Protocol relevant to their role.

• Where applicable ensure each Satellite Site maintains its own site Delegation Log separate to the Primary Site. Where the PI has delegated such a task to the Satellite Site Associate Investigator, the Associate Investigator will delegate duties appropriately, sign and date the log and send a copy to the Primary Site, when requested. 

1. The process for maintaining the Delegation Log across Primary and Satellite Sites may involve the use of wet signatures, scanned copies and/or e-signatures.

• Develop and complete a Supervision Plan before the commencement of a teletrial, which documents the manner and frequency of supervision to be undertaken between the Primary Site and each Satellite Site, and other study staff, especially Associate Investigators and other team members new to the role. The Supervision Plan must include cover for planned leave.
• Provide oversight, as outlined in the Supervision Plan, to any third party to whom any study-related duty or function is outsourced and take responsibility for any study-related duty or function performed and any data generated by the third party.

4. GCP Training

In accordance with the Clinical Trials Governance Framework, it is essential that clinical trial Investigators and clinical trial staff with significant delegated trial related responsibilities have access to and undertake training in the principles of GCP as a minimum requirement. Knowledge of GCP should be provided in a way that is proportionate to the individual’s role and level of trial activity. A trial risk assessment can be used to inform and justify the level of training, however the following minimum requirements apply:

Staff with significant trial related duties (all trials):

Core trial staff should receive TransCelerate accredited GCP training. Refresher GCP training should also be available to trial staff, at appropriate intervals to ensure that staff maintain awareness of current clinical trial standards and legislation.

Ancillary staff involved in trials with novel/non-routine interventions:

For staff conducting trial related procedures or involved in the care of trial patients/participants, GCP training may be in an abbreviated format; for example, taking the form of a short departmental trial awareness sessions covering relevant requirements such as:

• recording adverse events
• documenting activities in source notes
• notifying Protocol deviations and adverse events to the core trial team
• escalating any other issues identified to the core trial team. 

Staff provided abbreviated GCP training include:

• Pharmacy staff involved in general dispensing, under the oversight of a trial pharmacist who may perform training on relevant trial/GCP requirements.
• Laboratory/diagnostic staff undertaking routine tests used in a trial, under the oversight of a lead contact who may perform training on relevant trial/GCP requirements.
• Chemotherapy nurses with only the role of administering Investigational Products under the oversight of a day ward manager who has undertaken relevant GCP training.
• Ward or other staff performing routine activities within their scope of practice.

Ancillary staff involved in standard care trials:

Trials involving routine treatment (e.g. comparative effectiveness trials) often involve large numbers of healthcare professionals that are suitably qualified to undertake the trial by virtue of the prior education, training and experience, and work to quality systems outlined in their professional codes of practice. Consistent with the Clinical Trials Governance Framework, at a minimum, all trial staff should be made aware of the trial/relevant GCP principles (e.g. at routine meetings, short trial awareness sessions or provision of written materials).

Annexure

Nil

Revision History

Nil

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