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Form status flow

Within the Form Status Flow page, you can view flowcharts with statuses per each available CRF form for a specific study. These flowcharts include information about the statuses that forms have gone through already and their most recent status. Moreover, there is information about users who finalized the statuses and the time of status completion for each CRF form.

Viewing form status flowcharts
Figure 1. Viewing form status flowcharts

When viewing flowcharts, the following CRF form statuses are available depending on the current status of those forms:

  • Initial initial_icon_blue.png: a form is created but not yet filled out.

  • Completed completed_icon_green.png: a form has all the necessary data entered and is ready for review.

  • UnReviewed unreviewed_icon.png: a form is completed but a reviewer has requested to make some changes.

  • DM Reviewed dm_reviewed_icon.png: a form is reviewed by someone from the data management team.

  • Softlocked softlocked_icon.png: a form is reviewed and approved and no further changes can be made anymore.

  • Signed signed_icon.png: a form is signed by the investigator or the sponsor, indicating that they have reviewed and approved the data entered in these forms.

In this section:

A person responsible for managing and ensuring the integrity, accuracy, and confidentiality of data collected during clinical trials. The DM’s scope of work might include maintaining the quality of data, complying with regulatory requirements, and supporting the overall success of clinical research.

In the eClinical system, the Data Manager (DM) user role is granted to a person who is mainly responsible for cleaning the data, making sure the data is entered correctly according to all requirements and industry standards, and creating manual queries for clinical research coordinators on any questionable data pieces. Before the study goes live, works with the sponsor and receives and addresses their feedback to set up the study and CRFs in EDC in a way that the sponsor approves.

A person who is involved in a clinical trial and is designated to ensure that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. The clinical investigator must meet requirements set forth by regulatory bodies.

See also: principal investigator

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.