
The June 2004 article "Meeting the Challenges of Internet-based Clinical Trials" describes the current state of the art of Internet-based clinical trials. Just to ensure that the technologies do not rest on their laurels, the next generation of technology-e-source documents-will truly revolutionize clinical research. 

E-source documents will eliminate batch processing of data and almost all manual transcription, the presence of which guarantees an inefficient and error-prone data capture and reporting process.

Here is my wish list for e-source document technology: 

  Handwriting and voice capture for progress notes

  Real-time optical character, voice recognition, and progress note transcription (in a low-wage country)

  Real-time access to the informed consent form, protocol, investigator's brochure, etc. 

  Automatic time reporting (how long do study activities really take?)

  Real-time integration with sponsor's database for sophisticated data validation and queries

While we're at it, it's time to rethink the source document. Using current source documents is like singing a song with the words on one page (the source document) and the notes on another (the protocol). With a combined "scripted source document," we can eliminate a lot of wasted time and errors by integrating step-by-step protocol instructions with data capture fields.

All the technology to implement scripted e-source documents exists today. What are we waiting for?

News

Applied Clinical Trials-08-01-2004

Readers respond to articles and columnists.