Project Stages

The development of an EDC system for clinical research is a complex and consistent procedure. That is why we structured all the development processes and grouped them into design stages. Each stage has it's own set of standard operating procedures (SOPs) and reports. These documents help us to clearly follow the plan and to avoid mistakes during the preparation and configuration of OnlineCRF.

Following steps:

step 1
  • Calculate the preliminary price
    We calculate the price of services individually. EDC implementation cost is dependent on the volume of information in a CRF, the number of patients, the number of study sites and the duration of the project. The more complete information you provide, the more accurately we calculate the price of OnlineCRF. The request is processed within one day.
  • Adjust and agree on the final price
    To finalize the price, we analyze in details approved documents such as Protocol, CRF, the AE/SAE reporting forms and Statistical Analysis plan (if available). Then, we create general requirements for the OnlineCRF and prepare a detailed budget of the project. It takes 3-4 days.
step 2
  • Sign the agreement
    Before signing the agreement, we carry out a detailed analysis of the project, as well as agree on the terms and price of services. This preparation allows us to evaluate the project in detail and ensure all requirements of the Protocol. Signing the agreement is the starting point for the following activities.
  • Protocol and CRF provision to our team
    Once you provide us with these documents, the first step is an audit by our internal auditor. We analyze the completeness, integrity and consistency of the information in documents. This helps avoid errors and delays in the EDC system configuration during the project.
step 3
  • Protocol familiarization by a clinical data management team
    At this stage, the Head of the configuration team studies the protocol and extracts all requirements which are relevant to the data collection procedures. This approach helps reveal all project-specific requirements and creates the general outline of the project for the CDM team.
  • Data Management Plan development
    DMP provides information on how clinical trial data will be collected and processed in OnlineCRF. When drafting it, we work out in detail all the critical points that are important for the Data Collection, Storage, Data Cleaning, Backup and Disaster recovery.
step 4
  • System requirements development
    To appropriately set-up and configure the EDC system, we create a set of documents which play a role in system requirements. Hundreds of settings should be implemented correctly to configure the system in accordance with the specific project. System requirements allow us to not miss anything and serve as detailed instructions for proper system configuration.
  • CRF annotation
    EDC system can check the correctness of the entered data. If the user tries to enter some data which is out of the range, the system will show an alert. For example, you can’t enter a weight of more than 200 kg., because this value is out of range. But how does the system know which range is correct and which isn’t? The answer is that these ranges should be predefined in the CRF. The procedure of defining the correct data ranges is called “CRF annotation”. We expect that an annotated CRF will be prepared in advance. If not, we can have the CRF annotated by our experts.
step 5
  • Approval of all documents by customer
    After the project documents (i.e. annotated CRF, validation plan and EDC system specification) are prepared, they should be approved by the customer. This will help you understand how the system will look like and at what time you will receive the finished product to start a clinical trial. If changes are required, they will be easy to make at this stage.
  • OnlineCRF system deployment
    The OnlineCRF system works in online mode, all processes are processed on a secure web server. In order for the system to work correctly in online mode, its components should be transferred from the local storage to the server, and then properly configured. This is the deployment process.
step 6
  • OnlineCRF configuration
    System configuration is the process of setting up an OnlineCRF for a project according to System Requirements. At this stage, the matrix of visits is loaded into the system, and the user roles, AE/SAE reporting forms and many other things are configured. If necessary, the modification of standard functions of the system at the code level is done. Configuration procedures help form an EDC system for any project, even if it’s complex and non-standard.
  • eCRF implementation
    Once OnlineCRF is set up for a particular project, the implementation of the eCRF in the system takes place. Each visit is represented by one or several eCRF pages, which will be completed by the doctor. All required forms and reports are also created by data management team.
step 7
  • Edit checks configuration
    Automatic checks and valid ranges are configured for every field of eCRF. These checks are built to determine the required field, the type of entered data (number or text) and the correct range of values. These functions automatically check the entered data, mark questionable fields and enhance data quality.
  • OnlineCRF and eCRF validation
    If OnlineCRF has been modified to be compliant to specific protocol requirements, it should be validated. If the system was not modified, we conduct eCRF validation and prepare a full set of documents confirming that eCRF corresponds to paper CRF. Also, we check the correctness of all forms, checks, user rules, etc. This helps to ensure that the EDC system is fully compliant with the study protocol.
step 8
  • Preparation of complete set of validating documents
    After checking all the functions of the system, we form a set of validation reports. They confirm the validity of the configured system and the readiness to begin data collection.
  • Configured system assessment by client representative
    Following preparation and validation of the system, we have to make sure that it meets all customer requirements. Therefore, the finished product has to be verified by the Sponsor. We move to the next step if no errors and omissions are noticed.
step 9
  • User acceptance test (UAT)
    This step is highly recommended by GCDMP standard. UAT is performed by subject matter expert. In most cases, it is an experienced doctor who sees eCRFs from the study perspective. If something is not obvious for the end-user, and it is not very clear what data should be entered into the selected field, this point should be clarified. In the end, if everything is clear for the end user, UAT is successfully passed.
  • Training for sponsor representatives
    In many cases, OnlineCRF management rights during a data collection period are transferred to Sponsor. In these cases, we perform live online trainings for sponsor representatives. The training program is developed taking into account the role in the system of each participant. This will help you clearly understand how OnlineCRF works and what opportunities can be utilized.
step 10
  • Move the OnlineCRF system to production mode
    Upon completion of configuration and validation, we switch the system over to production mode. At this stage, the system is ready to create accounts for all users and to begin a trial (test) period.
  • Access granting to users
    When creating accounts for all users, we provide access to the system and also send relevant instructions to users. Finally, OnlineCRF is ready for data collection, and it will be supported by OnlineCRF team during the course of the study.
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