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Domain 5: Study and Site Management

Encompasses content required at the site level to run a study (financial and personnel aspects). Includes site and study operations (not encompassing regulatory/GCPs)


5.1

Describe the methods used to determine whether to sponsor, supervise or participate in a clinical study

Fundamental Level:

A1.       Demonstrate a basic understanding of baseline determinants of new study selection process at a research site

A2.       Understand the purpose of pre-site evaluation visits

A3.       Participate in virtual or face-to-face pre-site visits

Example: Given a new potential protocol, understands study-related needs in order to be able to do the study at the site, including

Skilled Level:

B1.       Provide input and guidance in the study selection process, including the ability to assess financial and logistical feasibility of conducting a study at the research site

B2.       Assist in organizing and conducting pre-site visits

B3.       Assist in estimating budgets for a potential study.

Example: Completes a feasibility assessment checklist for a new potential study, including preliminary budget estimates.

Advanced Level:

C1.       Guide study selection on a program or institutional level

C2.       Defend study selection decision-making, including determination of scientific validity and value; favorable risk/benefit ratio, and operational (logistical and financial) feasibility

C3.       Lead the negotiation, creation of tools, guidance documents, and policies to guide the decision-making process in study selection and participation

Example: Creates a study feasibility tool for use throughout department and evaluate assessments to make recommendations


5.2

Develop and manage the financial, timeline, and personnel resources necessary to conduct a clinical study

Fundamental Level:

A1.       Identify the component parts of a clinical trial budget

Example: Organizes study visits and requisite labs using correct requisition and account numbers for the study and is able to track and reconcile those documents.

Skilled Level:

B1.       Critique and recommend changes to proposed financial budgets, timelines, and amount/type of personnel necessary to conduct a clinical study

B2.       Monitor the progress of a clinical study towards milestones and identify trends or risks during study execution.  Implements mitigation plans

Example: Analyzes a study budget to ensure all requirements of the protocol are included.

Advanced Level:

C1.       Develop the budget, timeline and/or personnel resources to conduct a clinical study;

C2.       Identify trends and implement mitigation plans

C3.       Manage personnel that is assigned to the clinical study

Example: Generates amendments to a study budget and milestone timeline to reflect new requirements for an amended protocol and to address unforeseen cost issues for the conduct of a clinical study.


5.3

Describe the management and training approaches to mitigate risk to improve clinical study conduct

Fundamental Level:

A1.       Identify the mechanisms used in a research study that have been put in place to mitigate risk

A2.       Understand how risk assessments are conducted for clinical study operations and patient safety

Example: Articulates potential reasons why a key performance indicator might be compromised (e.g., study participants not completing study visits within the protocol-defined study window) and operations that might ensure lowest risk of occurrence.

Skilled Level:

B1.       Identify and understand the importance of the quality management plan (QMP) and teach others about the overall scope of the QMP

B2.       Implement risk mitigation steps as defined in the plan and develop a strategy to educate others on its content and application

Example: Analyzes reports and implement defined risk mitigation steps when key performance indicators have been triggered.

Advanced Level:

C1.       Develop both generalized and study-specific QMP training programs and delivers these programs to others.

C2.       Define key performance indicators for the clinical studies and incorporate them into the study specific QMP.

C3.       Interpret internal QA data on key performance indicators and strategize to mitigate risk through a corrective and preventive action (CAPA) plan.

Example: Analyzes and reports quality audit findings, presents them as discussion topics for mitigation strategies during staff meetings and/or incorporates them as part of quality management training programs to ensure staff understand how a QMS applies to a clinical study.


5.4

Develop strategies to manage participant recruitment, retention, compliance and track study activities.

Fundamental Level:

A1.       Articulate expected recruitment and retention rates

A2.       Identify and use tools, strategies, and procedures for implementation and tracking of participant recruitment and retention

A3.       Describe local and international regulatory requirements that impact the use of different recruitment tools

Example: Identifies documents and systems used to track recruitment and retention of participants.

Skilled Level:

B1.       Interpret subject recruitment and retention tracking data to determine if changes are needed

B2.       Develop basic methods for capturing and reporting on recruitment and retention

B3.       Apply local and international regulatory requirements to the use of different recruitment tools

Example: Creates a recruitment plan that addresses the needs of the study population with regards to age, gender, distance, and develops participant fliers for IRB submission that will aid in recruitment.

Advanced Level:

C1.       Innovate solutions to recruitment and retention challenges incorporating key ethical considerations.

C2.       Propose different recruitment tools based on regulatory requirements of each region / country

Example: Given a scenario of a study with fledgling recruitment or retention, the researcher creates innovative solutions that are evidence-based, clearly address the specific needs of hard-to-reach/engage populations. The solution includes plans for frequent review of the success of the strategies


Fundamental Level:

A1.       Organize and maintain study regulatory and grants/contracts documents for regulatory and institutional compliance audits

A2.       Understand purpose of study legal materials including: contract, budgets, indemnification, confidentiality disclosure agreements, conflict of interest reporting and IRB approvals in a compliant study site

Example: When asked by an investigator to obtain samples in the freezer to ship to another investigator for a lab-based research project, researcher at the Fundamental Level knows to seek additional advice to ensure that a materials transfer agreement is in place before making the shipment.

Skilled Level:

B1.       Organize and appropriately process contracts, materials transfer agreements, budgets, indemnification agreements, confidentiality agreements and conflict of interest reporting.  

B2.       Develop and/or follow SOPs that mitigate legal risks in conducting clinical trials

Example: Reviews an informed consent form to ensure that indemnification language in the Clinical Trial Agreement is in line with indemnification statements in the protocol and informed consent form and institutional policy.

Advanced Level:

C1.       Monitor systems and collaborate with institutional bodies to ensure compliance with legal and ethical requirements in the conduct of clinical research at the organization.   

C2.       Develop and critique risk mitigation strategies, associated action plans and issue resolution

C3.       Negotiate legal contracts (including budgets), confidentiality agreements, and conflict of interest documents

Example: Serves on a conflict of interest board for an institution

5.5

Identify the legal responsibilities, liabilities and accountabilities that are involved in the conduct of clinical studies


Fundamental Level:

A1.       Identify the regulations and guidelines that describe the requirements that apply to principal investigators, sponsors, CROs, and regulatory authorities in the conduct of clinical research

A2.       Describe roles of the site team members, including PI; sponsor, CRO, institution and FDA

Example: Catalogues and files all regulatory documents, including informed consent forms and recruitment materials necessary for an IRB submission.

Skilled Level:

B1.       Understand and articulate applicable regulations and accurately follow established processes in place to ensure compliance

B2.       Describe the various team roles (Sponsor, PI) and their responsibilities in the compliant conduct of clinical research.

B3.       Describe the impact of compliance on the safe and ethical conduct of clinical research studies

Example: Processes an IRB submission for a new clinical trial.

Advanced Level:

C1.       Apply advanced understanding of regulations and ability to accurately interpret regulatory guidance and mentor others in the translation of regulations into everyday practice.

C2.       Create strategies, policy and procedures to ensure regulatory compliance at a departmental or institutional level

C3.       Organize and manage regular study-related meetings with study staff and the principal investigators.

Example: Generates a delegation of authority log that clearly delineates staff roles in conducting a study according to levels of responsibility and scope of practice.

5.6

Identify and explain the specific procedural, documentation and oversight requirements of principal investigators, sponsors, CROs and regulatory authorities that relate to the conduct of a clinical study