IDMP might not only be about compliance to EU commission regulation it is also a journey towards better and more data control across business areas in the pharmaceutical industry.
As an example the IDMP data model for authorized medicinal product does not cover all data in the SmPC document and not all IDMP data is in the SmPC, but still for the data that is present both in the SmPC and the IDMP data model it is a valid question to ask – what source should be leading – data or document?
Before IDMP the document has been leading so question is if this should be changed with the implementation of IDMP.
The answer is it depends…
For the sake of simplicity we will continue this blog post by only addressing the example of the SmPC in respect to the data in the authorized medicinal product IDMP data model.
If your company have implemented or will implement structured authoring as part of implementing IDMP – data and document will be synchronized from the point in time where the text or a specific value in the document is created, changed or updated and tagged. Normally your structured authoring system will also propose what other documents that is using the same text section or the specific data value that was changed and should be considered for a similar updates – but structured authoring alone does not ensure alignment the regulatory workflow will also need to be considered.
As an example let’s discuss a variation or change that updates the clinical particulars with an additional adverse event/undesirable effect. In the regulatory workflow the SmPC is updated (ex. from version 3 to version 4) reviewed and approved from a document management perspective and send to health authorities in a variation package for regulatory approval. The current approved SmPC in the specific country is version 3 and version 4 is pending approval from authorities.
Even though the data and document is synchronized due to structured authoring and the data can be extracted automatically – it still needs to be controlled when to extract the data from version 3 or version 4 of the specific document in that country. The trigger will in this case be the approval of the version 4 SmPC from authorities. A possible source for this information could be your Regulatory Information Management System – RIMS or a similar system that contains a baseline of your regulatory approvals in each country. The system would need to contain a full list of your IDMP relevant documents as a baseline of your regulatory approval in respect to IDMP and the baseline would also need to be updated when changes/variations are approved by authorities.
If the regulatory baseline is controlled and structured authoring is implemented and both processes are well aligned – data can be considered as leading.
If data extraction cannot be automated via solutions like structured authoring a manual data entry solution must be made available. Making a reference to an earlier blog post discussing architecture choice the following options are available:
- EMA web interface
- IDMP application
- Data staging area (MDM solution)
If data is to be leading it would mean that data is created before or at least at the same time the document is created or updated and would push the data maintenance effort on to the author of the document to also maintain the IDMP data part before or simultaneously with creating, updating the document.
Without becoming to detailed option 1-3 can to our knowledge not handle multiple unapproved versions of your regulatory record in respect to the different regulatory variations that might be in process of being approved at health authorities at in the same time. Since the architecture does not support the needed functionality to support data as leading and data cannot be updated in the respective systems until the actual document is approved by health authorities – in this case document is leading.
If you are implementing an option 4 architecture you have to option to choose if data is leading or document is leading. As data then would have to be created by the author choosing data to be leading would mean that the manual data entry area in the data staging area would need to be made available to the author upon creation, update of the document. For the data that are to be send to IDMP via source systems like a RIMS system data updates would need to be controlled via tracking of Regulatory variations, but in either case it would mean that a full IDMP record matching the updated data set of the variations becomes available in the data staging area – in this case data is leading.
For architecture option 4 you can also choose to make document leading and in this case the data can be synchronized either when the document is approved internally or when the change/variation approval is received from health authorities.
As discussed above if data is leading update of IDMP is the responsibility of the document author. If document is leading you have the option to choose who is responsible for updating the IDMP data – in the example of the SmPC it will depend on where you want to place the responsibility and effort of doing the actual work of extracting the data and entering it to the manual data entry solution or source systems. A link should also be made to an earlier blog post discussing the maintenance strategy when collecting data from documents.
When deciding – current workload, system complexity and time to ensure the IDMP data capture must be considered. Possible options to consider could be:
- SmPC author in the regional office of the specific country
- Global Regulatory Responsible for the specific product
- Supporting team responsible for data capture
Should you place the responsibility of someone not involved in the process of writing the document it is probably best to wait until the document has been reviewed and approved from a document management perspective. Whether they are informed manually or automated when a new IDMP relevant document is created is not so important as long as they are able to initiate extraction upon approval of the document via a solid process.
Whether you choose structured authoring, capturing data early or late and if manual data capture is done by local office, global regulatory personal or a data capture team depends on your system landscape, current organization and the companies preferred choice in respect to workload and data responsibility.
The disadvantage of an early data capture is that the data also have to be maintained. It is never a given that heath authorities approve the first proposed text for a variation so in case things changes the document will need to be updated.
Advantage of an early data capture is probably a more simple process and early availability of the data.
What you choose and where you place the responsibility depends on your preference in respect to having data or document leading.
Blog written by: Jakob Juul Rasmussen, www.pharmait.dk