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Evolution Of Filing System In Clinical Research Industry

Evolution Of Filing System In Clinical Research Industry

Prasidha

Without Documentation Nothing is Done” is a well said saying that is often heard in a clinical research company. 

Hence documentation plays a very important role in a clinical research company. Documents need to be organized to have a flow of events so that they can be easily made available during any audit.

This led to the organization of the documents in separate sections and sub-sections for each activity. In order to maintain the uniformity in documentation, various forms and templates came into picture. The important and required data is captured in the forms and template during the clinical trial. These are placed into the separate sections of the files.

The files were maintained only as hard copies before the invent of electronic format of files. Some of the disadvantages of hard copies of files are:



  1. Storage of files became a major issue when the number of projects increases.
  2. Retention of the files was tedious after the closure of long-term study.
  3. Paper loses its quality and becomes illegible over a long period of time.
  4. Searching a document was a tedious activity when the number of documents for the study is high. 
  5. Auditing became a time-consuming activity.
  6. Reconciliation of documents is also a tedious task in case of paper files.
  7. They can be easily destroyed by natural calamities.
  8. There is higher risk of confidentiality breach.

Due to these disadvantages, the electronic format of filing came into existence, wherein a copy of a soft copy is also maintained along with the hard copy. This is similar to the existing folder system in our computers. Each folder has a subfolder with sections similar to the paper files. These folders are placed in a shared drive wherein the access are given to only the project team members.

Some advantages of electronic files over paper files are:

  1. Storage is not a major issue comparatively.
  2. For long term projects the electronic format of files can be made available even if the paper document is damaged due to some human error.
  3. The files can be instantly retrieved.
  4. The security and compliance can be better maintained due to the audit trial system.

Some disadvantages of electronic files are:

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  1. In present clinical trial system documents are generated initially on a paper and then scanned and placed into the folders. This does not eliminate the usage of paper completely.
  2. In case of any errors and corrections, the documents need to be scanned and rescanned again. This might lead to confusions.
  3. Each person might have a different understanding of placeholders used for each document. So, a document might end up in different locations.
  4. The reconciliation of documents is still a tedious task when the volume is too high. 
  5. The number of resources required for the process is also high.

In order to overcome the disadvantages of the electronic filing system and improvise the filing system, the filing system got collaborated with the artificial filing system.


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Advantages of AI in filing system are as follows:

  1. The classification of data and filing system is more organized as the filing of documents in appropriate sections rely mainly on the pre-defined rules rather than human understanding.
  2. The duplication of documents can be easily controlled.
  3. The pending documents can be easily tracked as the expected and filed document can be easily made available.
  4. There is higher security system maintained.
  5. The indexing or naming of documents rely on pre-defined nomenclature rather than human so there would be uniformity maintained in order in which the documents are present.
  6. Extra time of the resources can be utilized on quality check rather than uploading the documents.

The above said are only a few of the important advantages. With the evolution in the artificial intelligence field, there is further scope of improvising the filing system. This would not only benefit the filing system in the clinical research field but also in various fields.

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