15 January 2018
We received many positive comments and interesting questions on a previously published article about comparing the conduct of the bioequivalence study on paper and using EDC / IWRS systems. In addition, we are getting requests for DM services without using the EDC system.
We decided that it’s a signal for action. Let's look at all the arguments “for” and “against”:
First, the arguments "for":
1. The paper is cheaper! Especially if one site is involved.
2. In some hospitals, there is still unstable Internet. It is easier to work with paper forms.
Now let’s list the arguments "against":
1. You need a specific paper. Triplicates are printed on special equipment. To print Data Clarification Forms you need a dot matrix printer - and it also remained in the last century.
2. How to ensure data safety on paper? Are you ready to equip the vault and pass the checks? Everyone knows how easy it is to lose a piece of paper.
3. Logistics. It is very expensive to repeatedly send packets of documentation back and forth.
4. Human resources: First the Monitor checks the paper cards, then two different employees of the DM-company enter data into the electronic database, and the third employee merges it.
5. Data validity: verification is delayed, unlike EDC, where masks and checks are triggered instantly.
6. Data integrity: Parcels arrive at different speeds, you do not have a complete picture of the research at the current time, the data is disjointed. In the integrated system, you generate a report in real time by pressing a button, the system provides an analysis of the actions of all participants in the process, you control the progress of the research.
7. Using a paper you will receive a consolidated database only after the completion of a long and time-consuming process of importing and reconciling data from different sources.
8. And now imagine that an Amendment to the Protocol has been adopted. You will have to print and fill a ton of new forms.
So, colleagues, let’s return to the first list:
The paper is not cheaper. There are simply hidden costs that you did not take into account at the start. Your main expense is time. Time is money. Your competitor will be earlier on the market while spending fewer resources. But you work with the same investigators.
Paper is not easier. Here is a recent publication (in Russian), which at first glance supports the argument "for" under number 2. "Almost half of the Russian doctors do not have access to the Internet on a work computer."
Doctors complain that they are littered with paperwork, and "ask to create a system that is unified for the whole country." According to the plans of the Ministry of Health, by the end of 2018, 95% of the doctor’s workplaces <...> should be connected to the Unified State Health Information System in the country, so that the waiver of paperwork is faster. It is necessary to equip doctors' workplaces with high-speed Internet.
DM 365 invites you to make sure that a full and up-to-date level of service with the use of information technology is available to both organizers and executors of clinical studies. Send an e-mail or call us and we will gladly answer all your questions.