We have been dealing with clinical studies and in particular with eCRF for almost twenty years. In recent years the digital transformation has been very rapid in all sectors. In the world of clinical trials the discussion about the choice between paper CRF or electronic CRF, the so-called eCRF, is still open. Clinical researchers have not yet completely abandoned the huge amount of printed paper to fill manually patient’s data. There are, obviously, different reasons that lead to the choice of paper instead of electronic or vice versa. We argue that the choice of electronic CRF is winning in many aspects and in this post we want to highlight some arguments that are the result of our experience in the field.
eCRF – A question of responsibility
First of all, the electronic CRF guarantees the certainty of “data liability”. Whoever inserts or modifies the data is always identified in an electronic CRF. An eCRF system, compliant with the FDA 21 CFR part 11 recommendations and the European regulations about data tracing, records every data entry or modification . In this way it’s possible to report all the variations in chronological order with the indication of the user who made them and the type of modification made.
eCRF – Verification
As regards the reduction of transcription errors, there is no evidence in favor of eCRF, although some people argue that input errors are lower in the electronic CRF. However, the possibility of intervention is more immediate: monitors or data managers have promptly the possibility to request the revision of the data. On paper, this possibility is shifted when the data is transported on an electronic system, typically Access, Excel or SAS, and can thus be verified. In addition, in an eCRF a series of cross checks, the so-called edit checks, are implemented. This reduces the possibility of entering incorrect or inconsistent data. A correct analysis of these controls during the analysis phase of the eCRF greatly reduces the possibility of inconsistent entries with the source data.
eCRF – Immediacy
In an electronic CRF the actors of the study can monitor the trend of the trial already from the early stages through the reporting and the tools made available by the hosting system. In a paper CRF these data are not available in real time but often only after the completion of the paper CRF, when data is entered in electronic form. This gap is surely a dark point of the studies conducted in this way and can cause an enormous dispersion of energies for those who must inform the sponsors and other reference figures about the progression of the study. In a paper study the data is stored in a folder inside a closet. It is necessary to find the documents to carry out checks. In an electronic CRF the information is always available, the patient’s situation is complete as soon as we access to his form. The data requested is displayed immediately. There are no physical barriers, the clinical investigaator can also access to the system from another place and from another PC. He only needs to remember his login credentials.
eCRF – levels
In some studies it even happens that some information, such as questionnaires, can be compiled independently by the patient from a tablet made available by the center. With few indications of the personnel and a double access key with expiration time, the patients can insert the answers directly on the eCRF system. They can also use devices from their home to make recordings. Patients can enter data in a diary or take measurements and download data to the eCRF system. Obviously we can’t consider all these possibilities in a paper CRF clinical trial. In an electronic CRF the information can therefore be entered at various levels by different types of users. Users, such as laboratories, can insert laboratory data directly into the system. Each user has access only to the data of his competence. He can use only to the functions necessary to his profile.
eCRF – Security
An electronic study, if hosted by a system with a minimum of safety requirements, guarantees that the data does not risk to be left unprotected. The risk of leaving by mistake a patient’s file on a desk or a box of medical records in a hospital lane is certainly higher. Recently it has happened to us to come across a box waiting to be recovered.
A very important point for clinical trials is the randomization process, if is in the protocol. In paper studies an additional IVRS or IWRS type system is required to randomize patients who meet the inclusion and exclusion criteria. It is easier to make mistakes and include a patient who does not meet the requirements. Then it’s necessary to activate the related procedures to record the error. In an electronic system there is always a preliminary check that allows you to randomize only the patients that meet all the criteria. The system does not allow you to randomize otherwise.
eCRF – Speed
In CRFs, once the study has begun, it may happen that you have to revise the protocol. In a paper study this certainly involves printing or reprinting some parts. In an electronic CRF the changes are made to the system and are immediately available to everyone without any further time delays, with obvious advantages for all.
eCRF – Conclusions
All these benefits of electronic CRF must then be compared with a cost analysis to implement each kind of CRF. For this reason, often our customers or potential customers come to us to evaluate the choice also with an economic estimate based on the study protocol. With our eSmart system we can always be competitive on costs ensuring that all regulatory and safety requirements are met.
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