OpenClinica training for Investigators
The benefits of electronic CRFs (eCRFs) over paper-driven trials are well known. The use of eCRFs has the following main advantages:
- -Faster and cleaner data entry by sites
- -Remote site support and management
- -Flexible and enhanced monitoring
- -Integration of paper and computer entered data
- -Coordination of all subject data in one database (lab reports, IVRS, etc.)
- -Real-time reporting on both operational and clinical data
However due to the complexity of such systems and the strict legal requirements such systems need to fulfill, most e-CRFs on the market are quite expensive. Since a few years open source eCRFs are on the market which fulfill all the legal requirements. OpenClinica is such an excellent open source eCRF. The use of OpenClinica is quite simple. Nevertheless a good documented training of site staff and CRAs is part of the required validation process which ensures high data quality. Due to close timelines and limited budgets insufficient eCRF training of study staff often limits the benefits of electronic data capture (EDC).
GCP-Service has developed an online training for Investigators and CRAs who will work with OpenClinica. They can fit this training around their workload, stopping and resuming whenever that's convenient. By passing the corresponding test, proof is given that the Investigator is appropriately qualified for using OpenClinca, as defined in the ICH guidelines.
In a 30 minutes video, all aspects of OpenClinica that are relevant for an Investigator are explained in detail: from logging in for the first time to signing off the records after completion. Detailed examples are given for Discrepancy Management and helpful tips for better workflow.
Other topics are: your "Home" in OpenClinica, adding Study Subjects, shortcuts for quickly accessing a Subject, Scheduling Events, elements in the CRF-screen, required fields, Validations and error-messages, adding Notes, handling Discrepancies, marking CRF Complete, signing Subjects, etc.
Afterwards a multiple choice test needs to be passed. The test consists of 15 questions that will be generated randomly from a pool of questions. After each test the trainees will get a new randomized set of 15 questions. 80% of the questions need to be answered correctly to pass the test. 3 test repeats are possible. After the test is passed, the trainee receives a certificate which authorises the person to use OpenClinica.
The entire training has to be done within two months. If the period has expired and the test has not been passed, the online training has to be restarted.
Costs and Registration:
The fee of the online training is 150 euro plus 19% VAT (for non German persons with a VAT ID number no VAT will be charged).
After registration you will receive the username, password and the invoice. These login data are valid for two months. During this period you can pass the training modules and tests at any time. After two months your login data will expire.