Enrichment of incoming regular email


  • Enrichment of original/first incoming regular email

    • Theme selection

      • Corporate Entities

      • Corporate Projects

    • Theme - Corporate Entities

      • Corporate Entity - topic class

      • Corporate Entity - topic

      • Corporate Entity - subtopic

      • Corporate Entity - initial attachment processing

      • Corporate Entity - further attachment processing

    • Theme - Corporate Projects

      • Corporate Project - topic class

      • Corporate Project - topic

      • Corporate Project - activity/significant event

      • Corporate Project - initial attachment processing

    • Corporate Project - further attachment processing

  • Enrichment of incoming regular email replies

    • Regular email replies without attachment

    • Regular email replies with attachment(s)


Processing of incoming regular emails depends on whether the incoming regular email is the original/first incoming regular email in the correspondence or one of the incoming regular email replies in the correspondence.

The original/first incoming regular email receives full manual enrichment processing by the corporate end user.

Regular email replies are in most cases automatically processed by the Relational Email Server. The only exception is when the Theme is Corporate Entities and the regular email reply contains attachment(s). In this case, prior to processing, manual classification of the attachment(s) must be done by the corporate end user.


Enrichment of original/first incoming regular email


During the enrichment processing of an incoming original/first regular email the corporate end-user has to:

  • Chose a Theme (Corporate Entity or Corporate Project)
  • Chose a topic class from the List of Values (LoV) of the chosen Theme
  • Chose a topic from the personalized List of Values (LoV) of the chosen topic class
  • Chose a subtopic/significant event from the customized List of Values (LoV) of the chosen topic
  • Classify every attachment from the customized LoV of possible attachment types for the chosen topic/subtopic or activity/significant event combination

The List of Values (LoV) of the topics is personalized depending on the privileges of the corporate end-user.

The details of this process and other Enriched Email features related to registration of a received original/first regular email are elaborated below.


Theme selection


In general, registered email correspondence can relate to either a Corporate Project or a Corporate Entity.

At the very beginning of the registration process, a Theme has to be chosen which streamlines the process of incoming regular email registration.

The Theme of Corporate Projects or Corporate Entities must be selected.


Theme - Corporate Entities


Corporate Entity - topic class

If a Corporate Entity is selected as a Theme, a hierarchical List of Values of the corporate entity classes is displayed to chose from. Selected corporate entity class determines the possible topics of the incoming correspondence .

Corporate Entity - topic

For a selected corporate entity class a topic has to be chosen.

Depending on the selected corporate entity class a List of Values of the Corporate Entities of the selected class is shown to chose from. All personalized active Corporate Entities of the selected class are shown in the List of Values.

Selected Corporate Entity becomes the topic of the incoming correspondence.

Corporate Entity - subtopic

For the selected Corporate Entity as the topic, a subtopic has to be chosen. For Corporate Entities, subtopics are areas of interest related to the creation and development of a particular class of Corporate Entities. Whenever possible, they are adopted from the legislative regulatory documentation.

Depending on the class of the selected Corporate Entity the List of Values of the possible subtopics is displayed to choose from.

A list of Corporate Entities and the corresponding subtopics is presented here.

Corporate Entity - initial attachment processing

Optionally, if there is an attached document(s) to the email message, initial processing of the attached document(s) has to be done. Initial processing consists of classification of each attached document together with their automatic upload to the Corporate Documentation Cloud. Only the designated entity person or his Agent for the selected Corporate Entity can process the attached documentation.

If there is a need for further linkage with the Corporate Entities, "selection" feature of the Enriched Email is used and an appropriate List of Values is presented to chose from.

Document classification has to be done in accordance with the General Document Classification presented in the corresponding section of this site. Depending on the selected Corporate Entity topic/subtopic combination, a List of Values of the corresponding document classes is displayed to chose from. 

A list of corresponding documents for each corporate entity subtopic is presented here.

For instance, if the attached document is a person's CV, the list of contacts for the Organization selected as the topic is displayed to choose from.

All attached documents are uploaded with the status "initially processed" and, depending on the selected topic/subtopic combination, can be seen  on one of the entity change application forms for further processing. 

Further processing can be done by the designated entity person his Assistant or his Agent for the selected Corporate Entity.

Corporate Entity - further attachment processing

All "initially processed" attachments of registered email correspondence can be seen on the sub-application form "Correspondence" of the corresponding entity change application form.

The main objective of further documentation processing is to determine whether the incoming document(s) is "basis for change" of the Corporate Entity  and consequently, whether to initiate a Corporate Project to change the Corporate Entity.

Further processing can only be done by the designated corporate entity person his Agent or his Assistant for the Corporate Entity chosen as the topic in enriched email correspondence. When enough "basis for change" documents are gathered to determine the type of change proper "Variation" is selected and a Corporate Project is initiated.

The details of this process are described in the Corporate Entity section of this site for each type of Corporate Entity.


Theme - Corporate Projects


Corporate Project - topic class

If a Corporate Project is selected as a Theme, a List of Values of  standardized and customized corporate projects classes is displayed to chose from. Selected corporate project class determines the possible topics of the incoming correspondence.

 

 

Corporate Project - topic

Corporate Project - topic

For a selected corporate project class a topic has to be chosen.

Depending on the selected corporate project class a List of Values of the Corporate Projects is shown to chose from. The List of Values displays all personalized active Corporate Projects of the selected class.

Selected Corporate Project becomes the topic of the correspondence.

In certain situations "pointing" feature of the Enriched Email is used.

For instance, when corresponding with a Monitoring Organization regarding a Clinical Trial Realization Project involving several Investigational Sites, the Investigational Site may be selected to point to the Investigational Site as the subject of the correspondence.

Corporate Project - significant events

For the selected Corporate Project as the topic, current project activity is displayed.

The significant events in the realization of a Corporate Project depend on the type of Corporate Project and its current activity.

Depending on the type of the selected Corporate Project and its current activity, the List of Values of the related significant events is displayed to choose from.

For certain significant events , "completeness" feature of the Enriched Email is used.

For instance, for the significant event "Favorable opinion by IRB/IEC", the feature "completeness" is used to change project activity when all Ethical Committees provided positive opinions. Details for this example are provided in the "Clinical Trial Authorization Project" document.

The relation of Corporate Projects, their activities and related significant events is elaborated in detail in the section of this site related to Corporate Projects.

Corporate Project - initial attachment processing

Optionally, if there is an attached document(s) to the email message, initial processing of the attached document(s) has to be done. Initial processing consists of the classification of each attached document together with their automatic upload to the Corporate Documentation Cloud.

Document classification has to be done in accordance with the General Document Classification presented in the corresponding section of this site.

Depending on the type of the selected Corporate Project and its current activity, the LoV of the possible attached documents  is displayed to chose from. In case the attached document is based on a company template, automatic classification is provided.

The relation of Corporate Projects, their activitiesevents and related documents is elaborated in detail in the section of this site related to Corporate Projects.

Corporate Project - further attachment processing

Depending on the content of the email message and attached documents actions may be necessary from the involved pre-clinical, clinical, quality/cmc, regulatory and marketing entity designated persons.

Actions are initiated by issuing requests for Additional Info or eCTD editorial processing of relevant files.

Details of this process are described in the Corporate Projects  section of this site.


Enrichment of incoming regular email replies


Enrichment processing of incoming regular email replies depends on the presence of attachments.

For Corporate Projects, attachment classification is done automatically by the Relational Email Server, while for Corporate Entities, attachment classification must be done manually by the end user.


Regular email replies without attachment


For the regular email replies without attachments when the topic is one of the Corporate Entities:

  • the topic and subtopic cannot be changed - they are taken from the original/first email message 
  • enrichment processing is done automatically by the Relational Email Server
    • registration number is assigned automatically
    • forwards with the same registration number are automatically sent to the Agent and Assistant

For the regular email replies without attachments when the topic is one of the Corporate Projects:

  • the topic is the same and a significant event is the related correspondence
  • enrichment processing is done automatically by the Relational Email Server
    • registration number is assigned automatically
    • forwards with the same registration number are automatically sent to the Agent and Assistant

Regular email replies with attachment(s)


For the regular email replies with attachments when the topic is one of the Corporate Entities:

  • the topic and subtopic cannot be changed - they are taken from the original/first email message
  • enrichment processing is done partially automatically by the Relational Email Server
    • registration number is assigned automatically
    • classification of the attachments is controlled by the Enriched Email Client and is done manually by the end user
    • forwards with the same registration number are automatically sent to the Agent and Assistant

For the regular email replies with attachments when the topic is one of the Corporate Projects:

  • the topic is the same and a significant event is the related correspondence
  • enrichment processing is done automatically by the Relational Email Server
    • registration number is assigned automatically
    • attachments are classified automatically as related documentation
    • forwards with the same registration number are automatically sent to the Agent and Assistant