The document outlines a quality management plan for external clinical trial sites, emphasizing the need for individual Clinical Quality Management Plans (CQMP) tailored to each site's specific study protocols. It details essential components such as staff qualifications, facilities, participant access, competitive trials, and quality management practices, as well as a risk-based approach to identify and mitigate potential obstacles. Additionally, it emphasizes proactive quality management to enhance compliance, improve documentation, and create a supportive study environment.

1. Quality Management
Plan Outline for External
Sites
By C. L. Griffin, CCRP
31-AUG-2021

2. Starting Point: Review Site’s Profile.
Review the Site’s Profile including the following:
● Staff Qualifications: including staff availability, specialty, credentials, experience
in clinical research and the studied indication, and their study regulatory
compliance.
● Facilities and Equipment: adequate facility space, drug/device storage space
and security, types of source documents (eSoure/Paper Source), and equipment
needed for the study (i.e. BYODs, Electronic Platforms, QMS, etc…)
● Population Profile and Access: eligible participants’ availability and proximity,
disease/condition incidence, ongoing trials recruiting similar patients, and
recruitment capabilities including resources for conducting outreach.
● Clinical Trial Experience: including trials with similar enrollment timelines,
enrollment target, and complexity, and past enrollment rates.
● Competition: concurrent trials in the same indication or targeting the same
population profile that are ongoing or scheduled to start during study conduct.

3. Review Site’s Quality Management Practices.
● Confirm whether Site has a Clinical Quality Management Plan
(CQMP) Already Established
● If so, ask to review the Plan with Lead CRC or Site Manager (if
possible) and compare it to company’s policy parameters
● Check for adequate Quality Control Tools such as checklists,
workflows, daily review of collected source data forms, etc..)
● Check for adequate Quality Assurance Tools such as QM
Quarterly & Annual Audits of Essential Docs + participants’
charts, etc..)
● Confirm with the Sponsor/CRO plans for external monitoring
of the Site and ensure this is on the roadmap to be performed
regularly

4. CQMP Main Focal Points for External Sites
Primary Focus Points:
● Ensure each study site has its own CQMP per each study protocol (per our company’s policy
parameters)
● Incorporate A Risk-Based Approach when developing a CQMP for each site and NOT use a “one
size fits all” strategy for the planning and performing of a clinical trial
○ Identify obstacles and risk that would negatively affect the performance of a trial
○ Implement risk control plans and ensure these are communicated and followed by study
team
The following will be considered for each study site’s protocol CQMP:
● WHERE will quality matter the most or have the greatest impact, especially when considering
limited time and resources? i.e., – if study includes a study drug, dosing compliance and
accountability of the study drug
● WHAT specific problems have occurred previously? i.e., – if there were multiple errors in obtaining
consent
● WHERE is the risk to the subject, the study staff, the study site and/or data quality and integrity?

5. Components of External Sites’ CQMP.
The following will be included in the External Sites’ CQMP:
● Formal written document detailing CQMP (the Plan itself)
● Process Scope/Purpose per SOPs, GCP/GXP & all applicable regulations (FDA/EMA)
● Documentation of Education, Training & Qualifications
● Responsibility of PI, staff and their Involvement
● Ongoing QM Plan Maintenance
● QC + QA and Frequency of Activities
● Corrective Actions and Preventive Actions (CAPA) when warranted
● Process for Review and Trend Analysis
● Quality Improvement Plan and training/retraining of study staff
● QM Findings Entered into Spreadsheet/Database to track all SDV queries, trends
or other study-related issues
Below is Link to CQMP Checklist:
https://docs.google.com/document/d/1bm95D8_bFCfydx1beKjdZihEoyvjGVki/edit#

6. Study QA Audit Review Based on Complexity
Scale.
tt1bm95D8_bFCfydx1beKjdZihEoyvjGVki/edit#
Complexity
Level
Study Type Examples
High Prospective Phase I–III interventional procedure, device, and/or
drug studies (novel product or indication). All studies under an
IND or IDE with the FDA.
Medium Studies using FDA-approved drugs, devices, or biologics for their
approved indication. Other studies that do not meet high
complexity but are more than minimal risk (e.g., behavioral
intervention, complex observational, tissue collection).
Low Studies using procedures generally considered to be minimal or
low risk (e.g., blood sample collection, imaging not using
sedation, questionnaires, and behavioral surveys).

7. Complexity
Level
Regulatory
Reviews
Participant Chart Reviews -
By Cumulative Enrollment
1-39 40-49 >/= 100
High Quarterly
(every 3-
months)
Quarterly
3 records
Quarterly
10 % of
records
Quarterly
10 records
Medium Bi-annually
(every 6-
months)
Quarterly
3 records
Quarterly
10 % of
records
Quarterly
10 records
Low Annually
(once per year)
Biannually
3 records
Biannually
10 % of
Biannually
10 records
How QA Audit Will Be Conducted Per Complexity
Level.
Example Chart

8. EXAMPLE OF The Plan-Do-Check-Act Cycle for Quality
Management To Use For External Sites.
Step Action Stage of Cycle
(Scenario: Subjects not dating consent forms)
Identify the error in the process
and develop solutions
PLAN Who is authorized to consent subjects?
Is there a pattern?
How is the staff trained?
Are there other factors involved?
Develop a re-training plan
Apply the planned changes DO Retrain the identified staff
Measure the results by monitoring
and checking for any errors
CHECK Directly observe staff performing the consent procedure;
conduct an internal audit of the next 20 consent forms before
the subjects leave the site
Implement the plan on a wider
scale if all consent forms checked
have been signed; if unsigned
consent forms are still found, begin
ACT If dates are still missing, have subjects date their consent
forms, retrain staff or authorize another staff person to
consent incoming subjects, address/correct any other factors
that may be involved (i.e., overburdened staff or distracted staff

9. Contacting External Site - Goal: Build A Good
Rapport
Once a throughout review of the External Site’s Profile,
the study protocol + all parameters and the drafting of a
preliminary Risk-Based Approach Clinical Quality
Management Plan, the final step will be to reach out to
the site with the goal of establishing and building good
rapport and effective communication regarding the
Quality and Compliance Aspect of their study(ies).

10. Contacting External Site - Goal: Build A Good Rapport
continues…
The following will actions may or will be performed:
● After communicating with site, ensure a open, welcoming environment is
promoted
● Ensure the entire study team is aware of the process and expectation
● Meet with the entire study team to review the CQMP (annually or quarterly)
● Study team should schedule a time for everyone to conduct reviews. QC reviews can be
added to their calendars daily; this would allowed for designated time to complete QC
reviews (ideally QC activities should be done daily and in real time)
● Present and/or coordinate educational training/retraining sessions
● Create and distribute tip sheets on how to avoid compliance issues
● Make tools and resources accessible to facilitate compliance
● Be available for and willing to answer questions – serve as a resource/SME
● If possible attend feasibility processes, study KOMs, and SIVs
● Attend clinical staff team meetings to reinforce plan and clarify any misconceptions
● Conduct regular/routine retrospective reviews & audits

11. Anticipated Positive Results.
Traditionally, assessing quality has been reactive; errors are identified and
addressed after the fact
The ideal method of quality management is proactive
This involves the study team implementing quality measures into a study,
ideally at all stages of the study process (from feasibility, start-up, study
management, & close-out)
If an effective CQMP is in place this will:
● Lead to increased compliance to Protocol, SOPs, GCP and Applicable Regulations
● Improve documentation practices via ALCOA-C
● Enhance identification and resolution of data errors
● Decreases number of monitor findings & number of electronic data queries
● Prepare Site for unexpected FDA Audit
● Identify areas where education and training efforts should be focused
● Creates an environment of teamwork
● Empower Study Team to conduct their study(ies) with confidence and reassurance