Takeaways from July 27th, 2021 SCRS Panel Discussion on Regulatory Trends & Audit Preparedness


On July 27th, Clinical.ly CEO, Henry Kravchenko had the opportunity to speak on an SCRS Sites NOW panel to discuss Regulatory Trends and Audit Preparedness. Below is the summary of observations discussed on the panel. These observations are compiled from talking to sites, hospitals & academic institutions regarding data, data management, Part 11 compliance challenges, and best practices around these topics.

I. Data is the lifeblood of research. One factor we’ve observed is that sites that have agency over their data tend to have more efficient operations than their peers who exhibit less control. Efficiency manifests in multiple areas:

A. Speed of study startup

1. Sponsors asked sites to move faster during COVID – that expectation persists and having data readily available allows sites to keep moving at a faster pace.

2. Use of paper, Sponsor, or study-specific systems, results in loss of accuracy and efficiency.

B. Reduced time on data management & reduced operating costs

1. Sponsors’ study-specific systems prevent sites from leveraging prior work to organize & prepare data for subsequent studies.

C. Reduced staff turnover and reduced need for per diem staff.

1. SC’s & RA’s are not clerical workers and generally don’t want to be.

2. Repetitive & mundane tasks tend to lead to mistakes, but technology performs repetitive tasks exceedingly well and frees up staff to perform higher-value tasks.

D. Improved collaboration/communication with Sponsors, CROs.

1. Remote review is here to stay.

2. There was an uptick in on-site visits in Q2, 2021, but with the rise in COVID cases & the Delta variant, that trend reversed.

E. Audit preparedness & reduction in time Sponsors, CROs & FDA auditors spend on-site.

1. Since COVID, the FDA has conducted visits before study completion.

Having well-defined and automated data maintenance procedures improves multiple KPIs (key performance indicators) and mitigates regulatory and operational risk.


II. If you are managing in-house systems, Part 11 compliance becomes your responsibility.

A. A Part 11 compliant system must be validated to attest that it performs the expected functions in a way that is consistent with the documentation.

1. Sites approach to 21 CFR Part 11 compliance may be categorized in two broad categories:

a) Validate a system to fulfill regulatory requirements.

The second approach leads to faster adoption and, in our experience, leads to greater satisfaction.

b) Validate a system to educate staff on features, functions, and value and thereby coincidentally meet regulatory requirements.

2. Internally we use validation to train new employees on the product, so they are well versed in the entire system.

B. Documentation is another Part 11 requirement.

1. Good documentation will fulfill the Part 11 requirement & prove to be a valuable resource for understanding the functions and features of the system.

C. Changes to the system must be communicated and change history available for review.

1. Frequently, changes are communicated via release notes either in the product or via email.

2. A best practice is to leverage the release notes to learn about the features of the system. Doing so provides greater value to the site as the staff knows how to utilize more of the system.

D. Re-validation will be required when there are significant changes in functionality.

1. A quality vendor should provide you with updated validation scripts to help guide your staff on the features that needed re-validation.

E. SOPs must be in place and your vendor should provide template SOPs.

1. Access controls are critical & must be documented.

2. Since the vendor is the subject expert in the system, they should help you update your SOPs to include the use of the system.

Utilizing validation & leveraging compliance with Part 11 to learn the system rather than fulfill a regulatory obligation is significantly more efficient & leads to faster adoption.


III. Data maintenance is resource intensive. We have seen that it is common to underestimate the burden of maintaining quality data.

A. Disparate systems hinder delivering quality data and suck time from higher-value tasks, and some sites feel Sponsor provided portals are a significant source of wasted time. Some sources of mistakes are:

1. Lack of data consistency between studies.

2. Duplicate data entry across studies & even for a single study

B. Data “moves.” Organizing data once is inadequate as documents age, licenses expire, IRB boards change, etc.

1. It is essential to have a process in place to review & update your data. Ideally, this process is automated.

C. At times using multiple systems is unavoidable. Some of the best practices we have seen here are:

1. Establish a central repository of documents & data.

2. Designate a single person or persons to manage that data.

As study volume grows, these challenges grow exponentially, thereby increasing regulatory risk and operational burden.