Electronic Document Management system or eDMS is a computer-based program designed for creation, storage, retrieval and control of documents. eDMS are workflow based systems where a workflow is defined for each document from its creation to archival. This system helps in easy retrieval and exchange of information between various entities such as clinics, doctors, clinical researchers, etc. The information can be in the form of documents, reports, images, audio/ video files.
The main purpose of clinical trials is to gather evidence concerning safety and usefulness of a drug or medical device to convince the health authorities to approve. For this purpose, certain documents are created or collected during clinical research and trials which need to be submitted for compliance. Modern eDMS support both preparations of documents required for regulatory submission and eTMFs (electronic Trial Master Files).
Today, eDMS automate the co-ordination of documents needed for clinical trials and submission. They increase the efficiency of clinical trial documentation and submission, reducing cost and time required in preparation and submission of documants. Precisely, eDMS ensures availability of correct documents in right format at the right time to people who require them.
Steps for Effective eDMS
Regulatory submissions and clinical trials need & share several documents such as Investigator’s Brochure, clinical protocol, other documents appearing as study report appendices, Case Report Forms, Final Study report and any other documents to support the clinical trials authorization.
Establishing Ownership and Responsibility
The first step after identification is to fix the ownership of these documents by deciding who will create, review and approve the documents and also decide the system or module to be used at each step.
Ensuring Access to All Stakeholders
Once the ownership of documents is decided, these documents should be made available to all stake holders. It is important to decide whether the document would be available in its home location or would be made available to the concerned person based on who is responsible for creating /editing the document and who is only referring the document.
This ensures integrity of the information created and stored in eDMS and any change in the document is communicated to users referring to it by way of alert messages. Here users need a role-based access to documents.
The availability of documents needs to be automated. When a document is ready after approval it needs to be pushed into a specific folder which the user can access ensuringtimely availability of document to the concerned user. In case of any change in the original document a revised copy needs to be pushed into user folder. However, the cost of automation needs to be weighed against potential benefits in terms of saving in time.
Ensuring Submission Readiness
Documents required for submission have certain predefined format with certain fonts, margins etc. Scanned documents must adhere to certain resolution requirements to make the documents legible both in printed format and on computer screen. They must comply with regulatory requirements or it can result in lot of re-work at a later stage.
Consistency and Mining of Metadata
There should be consistency in product names, study titles and other information across the system. This helps in better navigation and easy search of documents. Use of consistent meta-data helps in smooth flow of data between various systems used within the organization and inter-operatebility with external databases.
A properly selected eDMS provides efficiency in clinical document management and the timely retrieval for clinical research and trials.