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FAQ - Aetiol™ Clinical

Aetiol™ – EDC

Aetiol™-EDC is New web-based software Solutions for Pharmaceuticals and CRO Applications,Providing End to End Partnership

Aetiol™ – Capture

The advanced Offline Clinical Data Management Software for capturing, managing and reporting clinical research data.

Aetiol™ – Encoder

Aetiol-Encoder is a web/Cloud based coding and dictionary management system that codes verbatim terms (VTs) from different systems.

Can I buld my own eCRFs and/or build my own studies?

Currently, Prelude builds the eCRFs using examples of paper CRFs (Case Report Forms) provided by the sponsor. This helps to standardize the eCRFs and leverages Prelude’s experience across hundreds of studies.

Future projects which utilize eCRFs are less expensive due to reuse.

eCRFs and paper CRFs are not the same. eCRFs have logic and edit checks built-in to run behind the scenes.

This allows the entered value to be cross-checked against normal ranges, or selected from a drop-down database, etc.
This logic and cross-form edits help to maintain a clean database throughout the entire duration of the study, which builds confidence in the outcome and results.

Can i reuse eCRFs from a library?

Yes, Aetiol™-EDC works closely with the Sponsor to drive standardization of eCRFs.

Aetiol™-EDC takes the next step by incorporating Sponsor-specific defined data terminology or naming conventions which help support biostats and data analysis.

How often can i access study data?

Your study database is available anytime, all the time

  • The server is live 24 hours per day, 7 days per week, 365 days per year.
  • Access is controlled by permission-based, secure user IDs and passwords.
  • Based on your User role, you may only have access to select forms and functionality.

Is Aetiol™-EDC in compliance with FDA 21 CFR Part 11?

Yes, Aetiol™-EDC meets the current guidelines for Part 11 for:

  • Electronic signatures
  • Proper Audit tracking
  • Life Cycle Process

Generally, Prelude only knows which regulatory agency the data will be submitted to based on information in the protocol and/or discussions with the Sponsor.

We rarely know the outcome of the submission unless it is shared by the Sponsor Company. We are aware that Aetiol™-EDC has been used for:

  • GLP / GCP submissions
  • USDA submissions
  • EPA submissions
  • EMA submissions
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Prelude suggests that your QA Group get involved and provide internal guidance.

Frequently Asked Questions - Aetiol-EDC | Aetiol-Capture | Aetiol-Encoder

Minimal training is needed to begin using Aetiol™-EDC. Development support is available in the form of:

  • Online tutorials and videos
  • Periodic training and refined user guides provided by support staff.
  • Contact with Aetiol™-EDC support staff regarding your issues or questions.

How much experience with programming, networking, and/or database construction is required to use and design EDC tools in Aetiol™-EDC?

No programming, networking, or database experience is needed to use Aetiol™-EDC. Simple design interfaces within Aetiol™-EDC handle all of these details automatically.

How do I access the collected data for advanced analysis at various points during the study?

Data from your study can be easily exported into Microsoft Excel.

How much experience with programming, networking, and/or database construction is required to use and design EDC tools in Aetiol™-EDC?

No programming, networking, or database experience is needed to use Aetiol™-EDC. Simple design interfaces within Aetiol™-EDC handle all of these details automatically.

How do I access the collected data for advanced analysis at various points during the study?

Data from your study can be easily exported into Microsoft Excel.

Can Aetiol™ Capture work outside the Intranet?

No.

Can Aetiol™ Capture study data integrated with Aetiol EDC?

Yes, it can.

Is Aetiol™ Capture is online or offline system?

Aetiol™ capture is a online system that works on intranet technology.

How much experience with programming, networking, and/or database construction is required to use and design EDC tools in Aetiol™-EDC?

No programming, networking, or database experience is needed to use Aetiol™-EDC. Simple design interfaces within Aetiol™-EDC handle all of these details automatically.

Is Aetiol™-EDC in compliance with FDA 21 CFR Part 11?

Yes, Aetiol™-EDC meets the current guidelines for Part 11 for:

  • Electronic signatures
  • Proper Audit tracking
  • Life Cycle Process

Generally, Prelude only knows which regulatory agency the data will be submitted to based on information in the protocol and/or discussions with the Sponsor.

We rarely know the outcome of the submission unless it is shared by the Sponsor Company. We are aware that Aetiol™-EDC has been used for:

  • GLP / GCP submissions
  • USDA submissions
  • EPA submissions
  • EMA submissions

Prelude suggests that your QA Group get involved and provide internal guidance.

How much experience with programming, networking, and/or database construction is required to use and design EDC tools in Aetiol™-EDC?

No programming, networking, or database experience is needed to use AetiolTM-EDC. Simple design interfaces within AetiolTM-EDC handle all of these details automatically.

How do I access the collected data for advanced analysis at various points during the study?

Data from your study can be easily exported into Microsoft Excel.

Are both dictionaries such as Meddra & WHO-DD are integrated with your Aetiol™ Encoder?

At present only Meddra is integrated with Aetiol™ Encoder.

Can Aetiol™ Encoder perform both automatic & manual coding?

Yes, it can.

Can your Aetiol™ Encoder either declassify or reclassify verbatim term ?

Yes, it can.

How many types of coding report Aetiol™ Encoder provides?

Aetiol™ Encoder provide 4 types of report that are mention below.

  • Coding glossary report:- It fetches the list of unique verbatim terms that can be used for review/correction/clarification of the coding for verbatim terms performed.
  • Listing Report:- It comprises of collected study data domain wise, it also includes all the dictionary items(full hierarchy of Meddra dictionary) as columns.
  • Coded VTs report:- It comprises of the list of coded verbatim terms.
  • Uncoded VTs report:- It comprises the list of uncoded verbatim terms that will be subjected to manual coding.

Is coding perform on real time basis?

Yes, the moment CRF is saved after entering the verbatim term the same will be subjected to coding by Aetiol™ Encoder instantly.

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