When you move to a new electronic trial master file (eTMF) system, leverage industry experience for a smooth process. Smart planning keeps your project running on time and on budget while remaining compliant.
Phase One: Plan the Move
Before you move to a new eTMF system, do the necessary planning to ensure the project goes smoothly. Here are a few quick points to consider.
Step 1: Assess Your Current Situation
Find Your Documents
While this sounds basic, complications can arise when there are:
- Differences in the filing structure between systems
- Documents filed in more than one system
- A single system holds a mixture of draft and final content
These filing situations will impact your strategy for retaining documents and the time needed for a move into your eTMF. Determine your approach to addressing these complexities and any impact on the time or document sources needed for the move. With the inventory and approach in hand, you can define the number of documents, the sources and under what conditions the documents should move to the eTMF.
Determine the Steps
Now that the source and target for your eTMF move are established, it is time to consider the steps. Fundamental questions include:
- Will there be any access barriers to getting to the source document, whether electronic or physical?
- How will the documents be moved? Manually or with a migration?
- How will document movements be secured, validated, and privacy maintained during the move?
- Which tools and expertise are needed to successfully make the move?
- How much time will be needed to migrate documents? Are there business constraints such as filings or inspections?
Once you answer those questions, you have a better understanding of the effort and resources needed. Next, assess the possible complexities in the eTMF move.
Step 2: Look at the Complexity of Your System
System complexities may result from specialized configurations or workflows. The age of your current TMF system will also influence the complexity. Over time, there are changes to the study and compliance requirements, the data and processes, and the rigors applied to maintaining standards. Together, configuration and system age become key factors in your migration analysis.
A high-quality business analysis is needed to identify and evaluate these scenarios as well as to articulate how the documents and data will appear in the new eTMF.
The next step is analyzing gaps in the metadata. The metadata available for the source system documents may have gaps or inconsistencies based on required fields in the new eTMF. Decide how to fill these data gaps and whether there is a need to create missing data, normalize inconsistent data, or to establish short-term system changes to accept the data gaps. Assure you have the time and SME resources to fill these gaps.
Phase Two: Keep the eTMF Compliant
TMF documentation requires that you can demonstrate:
- The approved document was created and filed on a timely basis
- The document’s complete and correct
- There’s no ability to modify the document after filiing
When moving documents, it’s important to demonstrate that the contents are not modified and remain secure. Manage this by documenting the chain of moves and the security controls for each step. You will need to conduct tests while approving and retaining evidence.
Metadata, including filing locations, will adjust to conform to the new eTMF system standards. Document the mapping rules and any data enrichment or transformation that occurred as part of the migration. Assure your migration plan clearly articulates the process and verification steps included in validating your eTMF migration. Here are a few key points to include in the validation documentation:
- Where did the documents or data come from? How were they chosen?
- What did you change for those documents or metadata to move into the new system?
- Who performed the steps in the migration?
- When did the migration happen?
- Why did you take that approach? What assumptions were built into the plan?
- How do you demonstrate that additional documents in scope were included in the migration?
- How did you prove the migration steps were completed as planned?
Keeping data and documents secure, and demonstrating compliance, are vital aspects of your successful move to a new eTMF.
Conclusion
Activity and compliance planning are critical tools to maintaining control of your eTMF migration and assuring your the completeness of your compliance documentation. Analyzing your TMF needs and proper planning will help ensure a smooth migration to a new eTMF system. You can also improve the odds of a successful move by hiring a clinical consultant.
Daelight Solutions partners with pharmaceutical, biotech and medical device companies to ensure successful eTMF system migrations. Find out how we can help by contacting us today.