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)
Describe the methods used to determine whether to sponsor, supervise or participate in a clinical study
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
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.
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
Develop and manage the financial, timeline, and personnel resources necessary to conduct a clinical study
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.
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.
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.
Describe the management and training approaches to mitigate risk to improve clinical study conduct
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.
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.
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.
Develop strategies to manage participant recruitment, retention, compliance and track study activities.
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.
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.
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
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.
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.
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
Identify the legal responsibilities, liabilities and accountabilities that are involved in the conduct of clinical studies
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.
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.
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.