Dacima’s flexible and easy-to-use Electronic Data Capture software comes with advanced features!

Designer module

Dacima Clinical Suite has a powerful designer module that lets you design electronic Case Report Forms and questionnaires without the need for programming expertise. Through a user-friendly web interface, you can configure the studies global parameters and create custom form. Design simple forms or using the many advance design features you to create sophisticated data entry forms with capabilities and data types not found in other EDC software. Dacima gives you more design flexibility and options than any other EDC software. Built in workflow  and version management allows you to create your study databases and  moves them to testing and production and version management allows you to create new versions of the forms even after the study has gone live.

No programming required

The Designer module allows you to create professional databases with no programming required.  Through an easy to use graphical web interface, you can access many design features and options not found in any other EDC applications. Dacima offers greater flexibility and design capabilities. All EDC system allows you to create basic data types, but only Dacima offers more advanced data types and options to give you the flexibility you need.

Advanced design features include:

• Dacima’s Designer module offers options that allow you to tailor your database for all kinds of different study designs: Clinical trials, observational studies (cohort, cross-sectional, case control), patient registries, post-marketing studies, ePRO, patient diaries, web surveys and telephone interviews.
• Next generation of advanced form design data types that allow you to create the most user-friendly and intuitive forms, including:
  • Subform to embed a form as a dynamic grid tables to collect as many rows as needed by the subject,  or display in form view.  Options to link and filter different subforms based on data already entered.
  • Design static tables with ability to move table cell position with the click of the mouse and merge options let you combine cells to create tables that look like you paper design.
  • Panels allows you to split your design screen into different sections.
  • Modal popups and list popups that makes collection complex data simple and intuitive.
  • Image-based data entry lets users enter data by clicking on zones of the images.
• Fixed list and adaptive randomization options.
• Partial date data type with an option to impute missing date parts.
• Wide variety of design parameters and options that allow you to tailor the workflow to your requirements and not the other way around.

Visit setup

In addition to setting up studies with fixed/predefined visit structures for longitudinal designs, Dacima also offers the ability to add dynamic visits that lets you add as many visits as needed for individual subjects. Dacima’s dynamic visit functionality is designed for patient registry or for trials that do not have a fixed follow-up visit structure.  Dynamic visits allow you to add a subject visit at any time based on the date of the visits.  

Hybrid visit structures

The system also allows you to create hybrid study designs with a fixed visit structure and a dynamic visit which can  be added for the subject as needed (such as for unscheduled visits in trial).  The designer module also allows you to choose from the standard subject selection interface or a dynamic visit interface designed specifically for patient registries that require dynamic visits.

Automatic scheduling
Subjects follow up visits are automatically scheduled. The scheduler projects the visits based on the study protocol and allows you to confirm it as a scheduled visit or change it as needed. With the built-in date range, the system also displays the acceptable visit date window and displays warning for visits scheduled outside of the acceptable date range.

Calender views with tasks management
The visit scheduler allows you to view monthly weekly or daily views as well as a subject’s complete visit schedule. Built in “task” list help you coordinate and manage the subject’s visits.

Custom configuration
The visit scheduler can also be configured to include ad hoc appointments that are not part of the visit structure of the study.

Hybrid inclusion forms
Dacima’s flexible design features allow you to create single forms or multiple forms for multistage subject inclusion/enrollment. In a single form design, the subject is included in the study database when the inclusion form is completed. Multistage designs allow you to create more than one inclusion forms which are completed sequentially.

Status tracking
The system tracks the status of the subject in the inclusion process. For example, an initial form can be used for the preliminary screening, and then followed by a second eligibility form that is completed after the results of lab tests are received. Once the stages are completed, the subject can be randomized. At each step in the process, the system tracks the status of the inclusion forms.

Create clickable fields on any image
Dacima’s unique image-based data entry feature allows users to enter data by clicking on regions or zones of an image. From the Designer module, the user can upload images and then, using the mouse, define regions or zones of the image that then become data entry fields. When the data entry users access the form, they can then click on the pre-defined zones of the image to enter data.

Dynamic subquestions
The system allows you for sub questions to appear based on the image zone that was selected and also allows for background colour of the zones to dynamically change based on the responses to questions on the eCRF.

Dacima Clinical Suite allows you to configure simple or complex validation checks through and easy-to-use web interface. No programming expertise required. With many built-in functions, the software allows you to set up advanced validation controls.

Validation rules:

• Field level (missing values and ranges)
• Validation checks across items on the same form
• Validation checks across items on different forms

Dependencies and piping:

• Visible and enable skip patterns within the same form or across different forms
• Colour dependencies let you change background colours to highlight questions dynamically
• Dynamic table rules to trigger allowable rows in dynamic tables based on other values entered.

Capture data in remote location
Dacima’s offline module facilitates a more efficient approach for electronic data collection in regions lacking web connectivity. The offline mode combines the benefits of web electronic data capture with that of a distributed offline database system. The system automatically generates a client application from the web database, replicating the interface of the web database with all the validation checks, form design features, data querying capabilities and data collection workflow of the original master web database.

Smart upload
Research staff can collect data electronically using the distributed database system without the need for internet access. When arriving at the clinical site/office, the software will compare the locally stored and server database and will only upload the changes that have been made to optimize low-speed internet access.

One super-administrator
The super-administrator access can be executed by the Dacima Design Team or can be given to the principal study manager. It allows you to create users and user groups and give them access to studies, sites, forms, dashboards, extraction and more.

Delegate rights to have complete control over your studies and everyone who accesses the database.

Item-level permission
Dacima Clinical lets you secure individual data entry fields so that only authorized users can access those fields. Protect confidential data and restrict access to only those users who require access to the data.

Form triggers
Form activation allows you to tailor the study database to display specific data entry form(s) based on values entered in trigger fields. You can design the study to display different forms depending on the treatment allocated to the subject, or activate or hide specific forms based on a variable such as sex.

Real-time study overview
The interactive dashboards are designed to give you an overview of important study metrics and data. Dashboards are dynamic and update based on user selections.

Various metrics
Users can choose from a variety of dashboards that provide metrics about subject recruitment, data query tracking, audit trail events, progression of data collection process, status tracking and summary statistics.

In-depth reports
The interactive reports allow you to modify the charts and display review general and detailed metrics. The dashboards also allow you to easily and efficiently go directly to the specific reports and data entry forms with the click of the mouse.

Advanced study management
Dacima Clinical Suite’s monitoring and verification module allows monitor users to review data, add data queries for discrepancies and electronically sign off on reviewed forms. The monitoring module allows monitoring plans to be defined, allowing you to review all patients or a random subset, as well as specifying which forms will be flagged for monitoring. The system allows you to create multiple monitoring plans and tracks the status of the plans.

Capture data from any device!
Dacima’s electronic patient-reported outcome (ePRO) module allows you to specify data entry forms for self-completion by the study subject. The module integrates with the Scheduler module and visits structure to automatically send subjects email reminders to complete the specified forms at the appropriate time.

Control your patient’s input
Status tracking and management features allow you to monitor the status of the questionnaires. Simplified ePRO interface allows for easy data entry by study subjects. Interviewer can activate the forms form self-completion on a computer or tablet, or trigger an automatic email to the subject with an embedded link to the ePRO forms.

Dacima’s web survey module is the most powerful web survey software on the market with the flexibility and options that lets you design all types of surveys (marketing, customer satisfaction, patient surveys, physician surveys, population surveys and more). Dacima Survey only web survey software designed with features specifically for medical/health research, including FDA 21 CFR Part 11 compliance, a complete audit trail, the ability to configure eligibility criteria form with checks, and ability to configure longitudinal survey designs. The software allows you to design simple or complex web surveys, through an easy-to-use web interface. No computer programming required! Dacima Survey has features and options not available in other open source and commercial software.

Dacima’s Patient diary allows subject to complete diaries or regular log entries. Accessible from computers, tablets or smart phones the Dacima’s diary module allows subjects to enter their data directly into the database through easy-to-use web forms. Automatic reminders ensure that subjects are notified if they fail to complete an anticipated entry.

21 CFR Part 11

Dacima Software complies with FDA regulatory requirements:

• Comprehensive and complete audit trails that track all changes to study data, and all user access, actions, and sessions
• Electronic signatures
• Access restrictions to protected health information (secure fields allow access by authorized users)
• Standard Operating procedures (SOPs) that protect data integrity and confidentiality

HIPAA

All products of Dacima Software are compliant with HIPAA.

HIPAA, the Health Insurance Portability and Accountability Act, sets the standard for protecting sensitive patient data. Any company that deals with protected health information (PHI) must ensure that all the required physical, network, and process security measures are in place and followed.

ICH-GCP

Dacima Software conducts its processes following Good Clinical Practice guidelines.

The Good Clinical Practice’s document describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs. GCPs cover aspects of monitoring, reporting and archiving of clinical trials and incorporating addenda on the Essential Documents and on the Investigator’s Brochure which had been agreed earlier through the ICH process.

Through Dacima CDISC wizard, you can create forms that allow you to generate SDTM compliant data. The easy-to-use wizard simplify the setup of CDISC compliant forms by selecting domains and fields. Dacima also allows you to output study databases in ODM compliant format and import ODM snapshot or transactional databases into Dacima Clinical Suite.

Dacima Clinical Suite integrates with the MedDRA dictionary and automates and simplifies adverse events coding. The system automatically searches the MedDRA hierarchies and preferred terms for the text entered in the adverse event fields. If adverse events codes are not found, the system identifies uncoded terms and allows the users to add corrected terms. This powerful coding functionality simplifies MedDRA coding.

“The WHO Drug Dictionary Enhanced™ (WHO DDE) assist pharmaceutical companies and CROs to secure better clinical data, speedup its analysis, and submit the results. It’s the most comprehensive and actively used drug reference work in the world – an indispensable source of medicinal product information for drug development and safety surveillance.”

Dacima Clinical Suite integrates with Rybbon, now BHN Rewards, a digital gifting platform that lets you automate and streamline the reward fulfillment process.

Now you can automatically send rewards to participants who have completed your trial or study rather than managing the process manually. They’ll get to choose incentives like e-gift cards, Visa and MasterCard Prepaid cards, or charitable donations. And with rewards that can be redeemed in more than 150 countries around the globe, you can incentive participants no matter where they live.

Dacima Clinical suite integrates with SaleForce to automatically transfer your SaleForce contacts mailing information to Dacima Clinical Suite web survey and electronic Patient Reported Outcomes (ePRO) mailing list features for sending study subjects invitations.

Dacima Clinical Suite offers Application Programming Interface (API) Web services for integration with third-party system for automatic data transfer.

Dacima supports ODM version 1.3 for clinical data POST and metadata POST and GET requests.

ODM is represented as an XML document and consists of a hierarchical tree of elements. These elements may have attributes which define their features. Elements and attributes in the Dacima Web Services API follow the CDISC ODM 1.3 standards and the ODM 1.3 rules on the hierarchy of elements.