Clinical Trials Projects
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Clinical Trial Projects and sub-projects
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Project sub-projects
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Entity sub-projects - Variations
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Clinical Trial Authorization Projects
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Monitoring Audit sub-projects
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Medicinal Product Paediatrics sub-project
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Medicinal Product Orphan sub-project
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Clinical Trial Realization Projects
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Monitoring Audit sub-projects
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SAE/SAR sub-project
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Clinical Trial Variation sub-projects
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To demonstrate the approach used to conduct the Corporate Projects a detailed presentation of the Authorization Project and Realization Project of the Clinical Trial, being the most complex scenario, is presented on this web page. Same approach is used for other Regulatory Projects.
Also, a similar approach can be extended to other business areas upon request. To cope with the complexity of the scenario all features of the Enriched Email are used, several of them developed especially for this situation.
Every Clinical Trial, as a fully structurally and narratively defined Corporate Entity, is the subject of two main Clinical Trial Projects, the Clinical Trial Authorization Project and the Clinical Trial Realization Project.
All information about Clinical Trial Projects is stored in Clinical Trial Dossiers segmented by active substance and country in which the authorizations and investigations are conducted.
In order to cope with the complexity of Clinical Trial Projects, sub-projects were introduced within the framework of Clinical Trial Authorization and Realization Projects.
When the first Clinical Trial Project is launched for a specific active substance in a specific country, a Corporate Entity, the Clinical Trial Dossier for the given active substance in that country, is automatically created.
The realization of subsequent Clinical Trial Projects for the given active substance in that country is treated as a change of that dossier.
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Clinical Trial Projects and sub-projects
Following types of standardized Clinical Trial Projects and sub-projects with predefined activities, milestones and significant events with classes of documents are recognized and defined:
- Clinical Trial Authorization Project
- Monitoring Audit sub-project
- Paediatrics sub-project
- Orphan sub-project
- Clinical Trial Realization Project
- Monitoring Audit sub-project
- SAE/SAR/SUSAR sub-project
- Variations - Competence of NCA and EC(s)
- Variations - Competence of NCA
- Variations - Competence of EC(s)
For most Clinical Trial Projects types and most sub-projects, several types of project initial submissions are generated during their execution, depending on the type of legal entity and Business Partners to which they will be submitted. Each type of project/sub-project follows the general business rules present in the Clinical Trials environment. The presented types can be easily adapted to any specific corporate needs or regulatory changes.
In the eCTD Integral Information System, each project/sub-project is assigned a core sequence, and their realization is tracked using the nomenclature similar to the electronic Central Technical Document (eCTD). Therefore, the first initial submission of the documentation for the Clinical Trial Authorization has the sequence number "0000" and so on.
For all types of projects/sub-projects, several types of initial submissions can be generated, each following internally defined rules.
All Clinical Trial sub-projects are related to the corresponding main Clinical Trial Authorization or main Clinical Realization Project.
There are two types of Clinical Trial sub-projects
- Clinical Trial Project sub-projects
- Clinical Trial Entity sub-projects - Variations
Project sub-projects
Four Project sub-projects are defined:
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Monitoring Audit
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Medicinal Product Paediatrics
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Medicinal Product Orphan
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SAE/SAR sub-project
Project sub-projects are initiated by a certain project significant event. For example, the significant event “SAE/SAR Notification” triggers the “SAE/SAR Project sub-project". The sub-project is started automatically during the Enriched Email processing of the “SAE/SAR Notification”. The project core sequence is initiated and the sub-project can be used as a topic in the enriched email correspondence with the pre-defined main activities, milestones, significant events and classes of documents. All subsequent activities of the sub-project are related to the newly opened project core sequence.
The start and end of each sub-project is recorded in the correspondence of the main Clinical Trial Project and consequently, can be seen in various reviews for managers and end users.
It is important to note that during the implementation of the Clinical Trial project sub-project, neither the structural nor the narrative essential change in the definition of Clinical Trial takes place. Neither the entity structural data nor the narrative entity definition documents experience any changes.
Entity sub-projects - Variations
Entity sub-projects - Variations are initiated by the receipt of one or more “basis for change” documents initiating the essential change to the Clinical Trial that is the subject of the Corporate Project. After processing by the Registered Email, further processing is carried out on the sub-application form “Correspondence” of the Clinical Trial application form. When the appropriate Variation is determined, the underlying entity core sequence is triggered and all subsequent Corporate Entity structural and narrative change activities are related to that sequence. When all the structural and narrative changes are defined a project core sequence and one or more project initial submission core sequences are automatically initiated. All subsequent project activities are related to that project core sequence and submission preparation activities to the corresponding submission core sequences.
It is important to note that during the implementation of the Clinical Trial entity sub-project, an essential structural and/or narrative change in the definition of the Clinical Trial occurs. Entity structural data and/or narrative entity definition documents experience an essential change.
All typified Corporate Projects are only examples to demonstrate capabilities of the eCTD Integral Information System. As can be seen, main Corporate Projects with submissions to several Health Authorities or Business Partners are supported. Also, several types of sub-projects with different integrated business rules are supported, which can be implemented in parallel with the implementation of the main Corporate Project.
Customization within this framework can be easily done by the introduction/deletion of the activities, milestones, significant events and classes of documents or by the introduction of new business rules.
Clinical Trial Authorization Projects
The Clinical Trial Authorization Project is automatically initiated when the clinical entity person declares the structural definition of the Clinical Trial complete. Depending on the structural data of the Clinical Trial, paediatrics and orphan sub-projects may also be initiated.
At the same time, Clinical Trial Authorization Project and all sub-projects become topics in the Enriched Email.
In the event that this is the first Clinical Trial for a given active substance, a dossier automatically opens where data on all Clinical Trial Projects with that active substance will be stored.
In case the Clinical Trial will be conducted in several countries, separate dossiers are open for each country.
Using structural data and applicable business rules, initial submissions are generated for authorization to the Ethical Committee(s) and Health Authorities.
Optionally, at the same time, initial submissions for paediatrics and orphan sub-projects are also generated. The clinical project persons in the countries where the Clinical Trial will be conducted are notified by automatically generated enriched e-mail notifications.
To assess the risk associated with the Investigational Site(s) where the Clinical Trial is planned to be conducted, the engaged Monitoring Organization may initiate a Pre-trial Monitoring Audit(s).
When all narrative definition documents are uploaded, clinical project persons are again notified with automatically generated enriched e-mail notifications.
Further conduct of the Authorization Project and sub-projects is done in accordance with predefined project activities, milestones and significant events of the corresponding project model. Pre designed models can be seen for:
It is important to note that all changes in the structural and narrative data that may occur during the realization of the Clinical Trial Authorization Project are treated as editorial changes and are submitted to the Health Authorities via related submissions as a response to their requests.
At the end of the Clinical Trial Authorization Project authorization data are entered into the eCTD Integral Information System. At that time, providing successful authorization results, initial submissions for the Clinical Trial Realization Project for the Sponsor and all Investigational Sites are automatically created and the Realization Project is started.
Clinical Trial Realization Projects
Since all structural and narrative data are completely defined, the Clinical Trial Realization Project is automatically initiated when the Clinical Trial Authorization is received from the Health Authorities and the authorization is processed using the appropriate application form.
Initial submissions for Sponsor and all Investigational Sites are automatically created in the appropriated dossier(s), and clinical project person(s) are notified by automatically generated enriched email notifications. At the same time, the Clinical Trial Realization Project becomes a topic in the Registered Email.
The project model for Clinical Trial Realization Projects with an Innovative Investigational Medicinal Product in one Country/State with one or more Investigational Sites is used to illustrate all the features and how the project model works.
The procedure assumes one Monitoring Organization, one central investigator and one principal investigator for each Investigational Site. The milestones, main project activities, and significant events for each project activity are defined. Also, for each milestone and significant event are accompanied by a corresponding corporate project document(s).
The procedure with comments for each significant event is presented here.
During the realization of the Clinical Trial Realization Projects both types of sub-projects can occur.
Monitoring Audit sub-projects
During the conduct of a Clinical Trial Realization Project, sub-projects may be initiated. Several types of monitoring audits/visits are regularly performed during the realization and for all of them a common project model is defined in accordance with governing legislative and business rules. As for the other cases, predefined project activities, milestones and significant events are defined.
Details of Monitoring Audit sub-project model are presented here.
SAE/SAR sub-project
During the conduct of a Clinical Trial Realization Project, serious adverse event/reaction may occur. They are also handled with a dedicated project model in accordance with governing legislative and business rules and with the predefined project activities, milestones and significant events.
Details of SAE/SAR sub-project project model are presented here.
Clinical Trial Variations sub-projects
Clinical Trial Variations can only occur during the implementation of the Clinical Trial Realization Projects.
To extend the approach used for Medicinal Product's Variations to Clinical Trial development/changes, a similar method/system was adopted and Clinical Trial Variations were classified into three different types:
- CT VAR-IEC-NCA Type
two competent authorities are involved - IRB/IEC and FDA/NCA - CT VAR-IEC Type
one competent authority is involved - IRB/IEC - CT VAR-NCA Type
one competent authority is involved - FDA/NCA
Detailed presentations of Clinical Trial Variation Project types with project activities, mutual interconnections of project activities, milestones, significant events, and classes of documents are presented:
For each Variation Type, several Variations are defined in order to demonstrate and test the models.
Additional Variations can be added or existing ones modified. Also, each Variation can be easily moved from one project model type to another.
List of proposed Clinical Trial Variations with corresponding model types is presented here.
Using milestones, project activities and significant events with predefined template documents along with other Enriched Email features, the progress of the Clinical Trial Realization Project along with its sub-projects can be monitored in real “real-time”.
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