CRA Best Practices: Foundations for Effective Study Management

Insights from a Lead Monitor and Data Manager

Clinical research studies require meticulous work to ensure high-quality data collection and successful regulatory submissions. In a recent webinar, AnnMarie Piano, independent consultant and former lead study monitor and data manager with 10+ years of industry experience, shared best practices for clinical research associates (CRAs) to support effective clinical research management.

Piano highlights two key areas where CRAs can help set the stage for study success: (1) participating in usability testing and providing feedback on the study database setup, and (2) ensuring clear timelines and adequate training prior to study kickoff.

The Role of CRAs

CRAs are essential to connecting the dots across the research team and ensuring study integrity. “[CRAs] are the link to the sites…, to the review, and to the hopeful approval of the product,” Piano explained. “It’s a very, very important role.”

To be successful as a CRA, Piano recommends a few core skills to develop:

1. Attention to detail: “It’s critical that you have attention to detail, that you have focus, that you like putting puzzles together.”
2. Communication: “You have to figure out how to communicate with people…so that they are willing to talk to you.”
3. Empathy: “You can’t tell [the sites] what to do; you can advise and guide…[let them] know you’re not going to be judgmental, that you’re going to help them, that you’re going to be kind when you do it.”

This trio of skills empowers CRAs to connect with sites, build trust, and tee up the study for higher data accuracy and integrity.

Evaluating the Study Build

Most modern studies use eClinical technology to streamline data entry and ensure data integrity, including Electronic Data Capture (EDC) systems and mobile apps for patient reported outcomes (ePRO). Before the study begins, CRAs can support study success by participating in user acceptance testing (UAT) and providing feedback on the usability of the EDC and any additional apps.

Piano highlights several elements to check for effective EDC implementation:

1. Protocol alignment: Does the EDC accurately reflect all protocol requirements? Piano recommends CRAs have the protocol in front of them and go through page by page to catch any missing fields or confusing forms.
2. Logical flow: Does the system intuitively guide users through each step? Does this flow match the logic outlined in the study protocol?
3. Built-in safeguards: Does the database have triggers, flags, and appropriate data ranges implemented to ensure data integrity?
4. Notification systems: Are controls in place to ensure proper alerts for adverse events, queries, and data changes?
5. Audit trail functionality: Is the system designed to track any data modifications with explanations? Is it easy to review a summary of all changes?
6. Visual appeal: Has the study builder created user-friendly screens without too much information on a given page? Piano notes that this is critical to ensuring sites accurately enter patient information and do not miss fields.

Preparing for Study Kick-Off

Once the study database is built and validated, Piano emphasizes the importance of planning and coordination upfront to ensure effective collaboration across the team throughout the study.

CRAs can support by ensuring that research teams:

1. Align the team upfront: Hold internal meetings to ensure everyone understands the protocol requirements, current study status, and timelines.
2. Work backward from submission deadlines: Start with the end date when the study needs to be completed and submitted, then work back from that date to schedule all activities accordingly.
3. Train on data collection methods: Ensure all internal team members are properly trained on the specific EDC system before approaching research sites. This can involve internal training or partnering with the eClinical solution provider.
4. Assess site readiness: When engaging with research sites, gauge their experience level with similar studies and familiarity with your EDC system. Make sure they understand the database interface and have the resources and training necessary to record data in line with the protocol and all regulatory guidance.

 By ensuring communication and alignment across research teams and the sites, CRAs can help lay the foundation for high-quality data collection throughout the study.

The Payoff for Planning Ahead

Piano explains that intuitive, clean database design and adequate team training and alignment is critical to ensuring data integrity and efficient study closeout. Without it, studies can risk missed assessments, incomplete data collection, time-consuming data cleanup, and potential regulatory approval delays.

In contrast, investing time in proper study setup and EDC design yields higher quality data with less data cleaning and a streamlined submission and approval process with comprehensive audit trails and fewer regulatory questions.

In Conclusion

By focusing on effective study build and proactive team alignment, CRAs can help their teams avoid common pitfalls and position their studies for success.

Ultimately, this drives greater efficiency throughout the study lifecycle, smoother approval processes, and higher odds of getting innovation in drugs, foods, and devices to market sooner.

To learn more, check out the full webinar recording below: