FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENT RULES, 2003

COMPLETE SPECIFICATION

(See Section 10 and Rule 13)

Title of invention:
AUTO CLINICAL DOCUMENT GENERATOR

Applicant
TATA Consultancy Services Limited
A company Incorporated in India under The Companies Act, 1956

Having address:
Nirmal Building, 9th Floor,
Nariman Point, Mumbai 400021,
Maharashtra, India

The following specification particularly describes the invention and the manner in which it is to be performed.

FIELD OF THE INVENTION:
The present invention generally relates to a document generation. More particularly the present invention provides a system and method for automatically generating a computer-accessible clinical trial related document from plurality of data sources.
BACKGROUND OF THE INVENTION:
Documentation of data, especially clinical trial related data is a complex and time consuming process. Because these clinical trial data generally relates to data associated with testing and analysis performed on newly synthesized drugs for several years before it is sold in the market, it becomes a serious issue to handle and manage the tested and analyzed data related to such newly synthesized drugs. Various trials are conducted for testing and analyzing the synthesized drugs and corresponding to which documents are generated each time. During the trial period, the manufacturers as well as drug regulatory authorities manages the generated documents for reviewing the merits and demerits of the said newly synthesized drugs. Upon completion of the review, it helps the concerned regulatory authorities to decide whether the drug should be sold in the market or not.
During clinical trials huge numbers of documents are to be created. Hitherto, creation of such clinical trial related document is manually performed. Such manual creation is not only resource and time consuming but also leads to inconsistencies and irregularities in the generated documents.
Hence, the lack of automatic generation of such clinical trial related documents and maintaining the consistency within the document still remains a need in the art. Moreover, yet another issue related to the document generation is to intelligently re-use the stored data and its attributes of the previously generated documents is an unaddressed problem in the art. So, there is a long felt need for a system and method for providing the auto-generation of a clinical trial document making use of the pre-stored components and maintaining the integrity of such generated documents.
OBJECTS OF THE INVENTION
The primary objective of the present invention is to provide a system and method enabling componentization of existing documents stored in a repository and assembling the components for authoring of a new clinical trial document.
Another object of the present invention is to provide a system and method for auto-generation of the clinical trial document in a desired format upon completion of aforesaid authoring process.
Yet another object of the present invention is to enable a method for creating re-usable content elements from the said existing document and storing said content elements in a componentized manner in the repository.
Yet another object of the present invention is to enable a method for creating the object elements by selecting the appropriate content elements which are created and stored in the componentized manner in the repository for authoring the clinical trial document.
Yet another object of the present invention is to provide a method for uploading an XML based document template(s) having componentized and stored content elements, wherein the said XML based document template(s) are tagged to the content elements which are used for authoring the clinical trial document.
Yet another object of the present invention is to enabling a method for selecting a study or a clinical trial for which the clinical trial document has to be authored.
Yet another object of the present invention is to enabling a method for selecting document template(s) corresponding to the selected study or the clinical trial for which the clinical trial document has to be authored.
Yet another object of the present invention is to enabling a method for receiving metadata information of the clinical trial document in the selected document template(s).
Yet another object of the present invention is to enable a method for importing and assembling the appropriate content elements along with their corresponding object elements required for authoring the said clinical trial document.
Yet another object of the present invention is to provide a method and system for enabling the re-use of the content elements and their object elements for further authoring and generating the clinical trial document.
Yet another object of the present invention is to provide a computer-implemented system having one or more processor executable modules for achieving the aforesaid objects of the present invention.
SUMMARY OF THE INVENTION
Before the present system and method, enablement are described, it is to be understood that this invention is not limited to the particular system, and methodologies described, as there can be multiple possible embodiments which are not expressly illustrated in the present disclosure. It is also to be understood that the terminology used in the description is for the purpose of describing the particular versions or embodiments only, and is not intended to limit the scope of the present invention.
The present invention introduces the computer-implemented system and a computer-implemented method for authoring the clinical trial document by componentizing the existing documents stored in the repository. Further, the said computer-implemented system and computer-implemented method is configured for assembling the componentized documents for authoring the clinical trial document.
In one aspect of the invention the computer-implemented system is provided for authoring the clinical trial document, characterized by assembling the componentized re-usable content elements and its corresponding object elements, wherein the said content elements and the object elements are stored in matrix based repositories, the said system comprises of various processor executable program modules including a creation module which is configured for creating the content elements by selecting the data type and data elements having associated data for providing information related to the selected data type in a componentized manner. The created content elements are identified upon the structure of the clinical trial document which is to be authored. The creating module is further configured for creating object elements by selecting the content elements which are created in the componentized manner. Optionally, the object elements can also be created manually. The created and componentized content elements and their corresponding object elements are stored in a master repository, said master repository comprises of a first repository for storing the componentized content elements and a second repository for further storing the object elements, said object elements are the instances of their corresponding content elements. After the creation of the content elements and the object elements, an uploading module is configured for uploading a XML based one or more document templates having the created and componentized re-usable content element tags, wherein the said uploaded one or more document templates is further used for authoring the said clinical trial document and are stored in the master repository. A selection module is configured for selecting at least one study or a clinical trial for which clinical trial document has to be authored and further configured for selecting the suitable document template from the previously uploaded document templates which are stored in the master repository, wherein the suitable document template are selected corresponding to the selected study or the clinical trial. A receiving module is configured for receiving the metadata information of the said clinical trial document in the selected document template. The said metadata information can be a header and footer information, author name, version, document title and any logos.
Further, an importing module is provided which is configured for importing and assembling the appropriate content elements and their corresponding object elements for authoring the clinical trial document. Upon completion of authoring of the said clinical trial document, the authored clinical trial document is generated in a desired format.

BRIEF DESCRIPTION OF THE DRAWINGS
The foregoing summary, as well as the following detailed description of preferred embodiments, is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there is shown in the drawings various stages of the invention; however, the invention is not limited to the specific system components and methods disclosed in the drawings.
Figure 1 is the block diagram of the system (100) illustrating the multiple embodiments of the present invention.
Figure 2 is the illustration of the importing and assembling process (200) for authoring the clinical trial document performed by the importing module of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
The invention will now be described with respect to various embodiments. The following description provides specific details for understanding of, and enabling description for, these embodiments of the invention. The words "comprising," "having," "containing," and "including," and other forms thereof, are intended to be equivalent in meaning and be open ended in that an item or items following any one of these words is not meant to be an exhaustive listing of such item or items, or meant to be limited to only the listed item or items.
The invention generally provides the computer-implemented system and computer-implemented method for authoring the clinical trial document using an auto-clinical document generator, characterized by enabling the auto-clinical document generator for assembling the componentized re-usable content elements and its corresponding object elements, wherein the said content elements and the object elements are stored in matrix based repositories.
In one embodiment of the present invention the computer-implemented system provides the auto-clinical document generator, which is a tool, wherein the said auto-clinical document generator comprises of various processor-executable program modules, each module performs a particular set of task upon execution of the processor. One of the modules of the auto-clinical document generator is a creation module which is configured for creating the content elements by selecting the data type and data elements having associated data for providing information related to the selected data type in a componentized manner. The created content elements are identified upon the structure of the clinical trial document which is to be authored. The associated data includes the formatting information of the document template such as category i.e., structured or un-structured, data type i.e., textbox, table, image or option, font-name, font-size, section-format i.e., body-text, Heading 1, Heading 2 or Heading n (where n can be any positive number), bold, italics, underline or combination thereof. The content elements act as a placeholder for the actual data which will be used for authoring the said clinical trial document. Authoring of said clinical trial document is done by grouping of the content elements. However, the content elements are not tied to their respective document(s) and exist independently. Thus, the content elements can be re-used during the authoring of the clinical trial document. The creation module is further configured for creating the object elements by selecting the created content elements which are created in the componentized manner. The object elements are the instances of their corresponding content elements which stores the said actual data which are used for authoring the clinical trial document. The object elements can also be created manually. Both, the content elements and their corresponding object elements which are created for authoring the clinical trial document are stored in the master repository in the componentized manner. The content elements are stored in a first matrix-based repository whereas their corresponding object elements are stored in a second matrix-based repository.
From the created and stored content elements and their corresponding object elements, an uploading module upon execution of the processor is capable of uploading an XML based document template(s), said uploaded document template(s) are composed of the created content element tags which are used for authoring the clinical trial document. The said created content element tags and their corresponding object elements are componentized and are re-used during authoring of the said clinical trial document. Also, the uploaded document template(s) are stored in the master repository.
After completion of creating and componentizing of content elements and their corresponding object elements and thereafter uploading the document template(s), one of the said processor-executable program module i.e., the selection module further executes the authoring process, said selection module is configured for selecting a particular study or the clinical trial for which the clinical trial document has to be authored. It should be understood for the person skill in the art that according to the present invention, the clinical trial documents can also be authored for different studies selected by the selection module and the present invention is not limited to a particular study only. Corresponding to the selected study or the clinical trial, the selection module is further configured for selecting the suitable document template(s) from the previously uploaded XML based document template(s) which are stored in the master repository.
Upon selecting the study or the clinical trial and its corresponding suitable document template(s), the receiving module is configured for receiving the metadata information of the clinical trial document which is to be authored in the selected document template. The said metadata information can be a header and footer information, author name, version, document title and any logos.
Upon receiving the said metadata information, the auto-clinical document generator displays the content elements which were created for authoring the clinical trial document on the display panel in a tree view. From the displayed content elements, the importing module upon execution of the programmed instructions stored in the memory of such importing module is configured for importing and assembling the each and every appropriate or required content elements based upon that, the instances of the imported and assembled content elements i.e., the object elements are further displayed and imported by the importing module for authoring the clinical trial document. The said appropriate content elements and object elements are imported from the master repository where they are stored. Optionally, the present invention also facilitates for selecting and importing the displayed content elements and their corresponding object elements manually. The imported object elements store the actual data which is required for authoring the said clinical trial document. The clinical trial document gets generated in the desired format i.e., Microsoft Word format, an Adobe Portable Format (PDF) or combination thereof.
In another embodiment of the present invention the computer-implemented method is considered for authoring the clinical trial document, characterized by assembling the componentized re-usable content elements and their corresponding object elements, wherein the content elements and the object elements are stored in the matrix based repositories. For enabling the authoring process, set of processor-enabled steps are performed by the processor-executable programmed modules, wherein the said steps includes; creating the content elements by selecting the data type and data elements having the associated data for providing information related to the selected data type. The said associated data includes the formatting information of the document template such as category i.e., structured or un-structured, data type i.e., textbox, table, image or option, font-name, font-size, section-format i.e., body-text, Heading 1, Heading 2 or Heading n (where n can be any positive number), bold, italics, underline or combination thereof. After creating the content elements, the object elements are created by selecting the created content elements, wherein the object elements are the instances of the created content elements. Creation of the content elements and the object elements are performed by the creation module and are further stored in the master repository. The created content elements are stored in the first matrix-based repository and the created object elements are stored in the second matrix-based repository. Both, first and the second matrix-based repositories are stored in the said master repository, wherein the said master repository is configured for storing the created content elements and their corresponding object elements in the componentized manner.
Upon creating the content elements and their corresponding object elements, the step for uploading of the XML based document template(s) is performed by the uploading module, one of the processor-executable programmed modules. The uploaded document template(s) are composed of the created content element tags, wherein the said created content element tags and their corresponding object elements are componentized and are re-used during the authoring of the clinical trial document. The uploaded XML based document template(s) are also stored in the master repository.
After creating and storing the content elements and their corresponding object elements and thereafter uploading the said XML based document template(s) which are tagged to the created content elements, the authoring process further executes by selecting the particular study or the clinical trial for which the clinical trial document has to be authored. It is to be understood for the person skill in the art that according to the present invention, the clinical trial documents can also be authored for different studies or clinical trials selected by the selection module and the present invention is not limited to a particular study or clinical trial only. The selection of the particular study or the clinical trial is performed by the selection module upon execution of the processor. The said processor-executable selection module is further configured for selecting the suitable document template(s) from the previously uploaded XML based document template(s) which are stored in the master repository.
Upon selecting the study or the clinical trial and the said suitable document template(s), the step for receiving the metadata information of the clinical trial document which is to be authored in the selected document template is performed by one of the processor-executable programmed module i.e., the receiving module. The said metadata information can be a header and footer information, author name, version, document title and any logos.
Upon receiving the metadata information, the content elements which were created for authoring the clinical trial document are displayed in the tree view. From the displayed content elements the step for importing and assembling the appropriate content elements from the tree view is performed upon execution of the programmed instructions stored in the memory of such importing module. The said importing module is configured for importing and assembling the appropriate or required content elements based upon that, the instances of the imported and assembled content elements i.e., the object elements are further displayed and imported by the importing module for authoring the clinical trial document. The said appropriate content elements and object elements are imported from the master repository where they are stored. Optionally, the present invention also facilitates a method for selecting and importing the displayed content elements and their corresponding object elements manually. The imported object elements store the actual data which is required for authoring the said clinical trial document. The clinical trial document gets generated in the desired format i.e., Microsoft Word format, an Adobe Portable Format (PDF) or combination thereof.
Thus, the above described computer-implemented system having the processor-executable programmed modules and the computer-implemented method having the said processor-enabled steps performed by the said processor-executable programmed modules are provided for authoring the clinical trial document.
Next, the preferred embodiments of the present invention will be described below based on drawings.
Figure 1 is the block diagram of the system (100) illustrating the multiple embodiments of the present invention. The system (100) comprises a processor, a memory, a master repository (118) and the auto-clinical document generator, a tool, wherein the said auto-clinical document generator further comprises of a set of processor-executable programmed modules such as a creation module (104), an uploading module (106), a selection module (108), a receiving module (110) and an importing module (112). The said auto-clinical document generator may be connected to the external data source over a communication network for authoring the clinical trial document. In accordance with various embodiments of the present invention, the methods described herein are intended for operation as computer programs modules running on a computer processor.
The creation module (104) is configured for creating the content elements by selecting the data type and the data elements having associated data for providing information related to the selected data type in a componentized manner. The associated data includes the formatting information of the document template such as category i.e., structured or un-structured, data type i.e., textbox, table, image or option, font-name, font-size, section-format i.e., body-text, Heading 1, Heading 2 or Heading n (where n can be any positive number), bold, italics, underline or combination thereof. The created content elements act as a placeholder for the actual data which will be used for authoring the said clinical trial document. However, the content elements are not tied to their respective document(s) and exist independently. Thus, they can be re-used during the authoring of the clinical trial document. Further, the creation module (104) is also configured for creating the object elements by selecting the created content elements which are created in the componentized manner. The object elements are the instances of their respective content elements and store the said actual data which are used during the authoring of the clinical trial document. The created and componentized content elements and their corresponding object elements are stored in the first and the second matrix-based repositories (not shown in the figure) respectively. The said first and the second matrix-based repositories are stored in the master repository (118).
Upon creation of the content elements and their corresponding object elements, the uploading module (106) upon execution of the processor uploads the document template(s) (116), wherein the document template(s) are composed of the created content element tags which are used during authoring of the clinical trial document. . Along with the created and componentized content elements, their corresponding instances i.e., the object elements are re-used during authoring of the clinical trial document. The uploaded document template(s) are XML based and are tagged to the created content elements and are stored in the master repository (118).
After the creation, componentization and storing of the content elements and their corresponding object elements and thereafter uploading the XML based document template(s) having content elements tags, the said processor-executable selection module (108) is configured for selecting a particular study or a clinical trial for which said clinical trial document has to be authored. A group of studies (102) are shown in the figure from which a particular study is selected. In the present scenario “Study 3” is selected by the selection module (108). Corresponding to the selected study i.e., “Study 3”, the selection module (108) is also configured for selecting the suitable document template from the group of the previously uploaded document templates (116), wherein the selected document template in the present scenario is “Document Template 3”. Further it should be understood for the person skill in the art that according to the present invention, the clinical trial documents can also be authored for different studies or clinical trials by selecting their corresponding document templates which can be selected by the selection module (108) and the present invention is not limited to a particular study or clinical trial only.
Upon selecting the study and its corresponding document template(s), the receiving module (110) is configured for receiving the metadata information (114) of the clinical trial document which is to be authored in the selected document template i.e., “Document Template 3”. The said metadata information (114) can be a header and footer information, author name, version, document title and any logos.
Upon receiving the metadata information (114), the auto-clinical document generator displays the content elements which were created for authoring the clinical trial document on the display panel (not shown in the figure) in a tree view. From the displayed content elements, the importing module (112) upon execution of the programmed instructions stored in the memory of such importing module (112) by the processor is configured for importing and assembling the appropriate or required content elements based upon that, the instances of the imported and assembled content elements i.e., the object elements are further displayed and imported by the importing module (112) for authoring the clinical trial document. The said appropriate content elements and object elements are imported from the master repository (118) where they are stored.
Optionally, the present invention also facilitates for selecting and importing the displayed content elements and their corresponding object elements manually. The imported object elements store the actual data which is required for authoring the said clinical trial document. The clinical trial document gets generated in the desired format i.e., Microsoft Word format, an Adobe Portable Format (PDF) or combination thereof.
Figure 2 is the illustration of the importing and assembling process (200) for authoring the clinical trial document performed by the importing module of the present invention. Upon selecting the study or a clinical trial for which clinical trial document has to be authored and further selecting its corresponding document template(s) (206) by the selection module (108 of figure 1), the receiving module (110 of figure 1) is configured for receiving the metadata information (114 of figure 1) of the clinical trial document which is to be authored in the selected document template(s) (206). The said metadata information (114 of figure 1) can be a header and footer information, author name, version, document title and any logos.
On receiving the metadata information (114 of figure 1), by the receiving module (110 of figure 1), the content elements which were created by the creation module (104 of figure 1) are stored in the master repository (118 of figure 1). The stored content elements (202) of the master repository are {CEA, CEB, CEC and CEn} as shown in the figure. Further, the creation module (104 of figure 1) also creates the object elements (204) i.e., {OEA1, OEA2, OEA3, OEAn, OEB1, OEB2, OEB3, OEBn, OEC1, OEC2, OEC3, OECn, OEn1, OEn2, OEn3 and OEnn} which are randomly stored in the master repository (118 of figure 1).
Based upon the selected study as per the present scenario i.e., “Study 3”and its corresponding document template (206) i.e., “Document Template 3”, the content element tags (208) i.e., {CE – TagA1, CE – TagB1, CE – TagB2, CE – TagC3 and CE – Tagn3} are displayed. The importing module (112 of figure 1) imports the appropriate or required content elements and corresponding object elements from the master repository for each displayed content element tags which are displayed in the document template (206). The importing module (112 of figure 1) imports and assembles the object element OEA1 of the content element CEA1 for the selected and displayed content element tag CE – TagA1. Similarly, the object element OEB1, OEB2 , OEC3 and OEn3 are imported and assembled for the selected and displayed content element tags CE – TagB1, CE – TagB2, CE – TagC3 and CE – Tagn3 respectively by the importing module (112 of figure 1) as can be seen from the figure.
Thus, upon completion of the importing and assembling of the appropriate or required content elements and their corresponding object elements for each displayed content element tags, the clinical trial document gets authored (210). Further, the authored document (210) can be generated in a desired format i.e., Microsoft Word format, an Adobe Portable Format (PDF) or combination thereof.
Thus, the computer-implemented system having the processor-executable programmed modules and the computer-implemented method having the said processor-enabled steps performed by the said processor-executable programmed modules is provided for authoring the said clinical trial document, wherein the said document is generated in the desired format.

BEST MODE OF CARRYING OUT THE INVENTION
According to the present invention, a computer-implemented system and the computer-implemented method is configured for providing a auto-clinical document generator for authoring the clinical trial document, characterized by assembling the componentized re-usable content elements and its corresponding object elements. In the real life example defined here for authoring an eProtocol document i.e., the clinical trial document.
According to an exemplary embodiment of the present invention, eProtocol document is considered for authoring. The various steps of the process used to perform this clinical trial document authoring are as follows:-
A. The structure of the considered clinical trial document i.e., “eProtocol” document is analyzed and the content elements which are required for authoring the document is identified.
B. In this exemplary embodiment of the present invention, the identified content elements which is to be created for authoring the eProtocol document is listed below: -
• Study type
• Objective
• Inclusion-Exclusion
• Time and Events
• Study Phase
• Logo
C. Upon identifying the required content elements, the creation module of the present invention creates the identified content elements by selecting data type and data elements. The expected data type to be stored with the created content elements are shown below:
• Study type - Text
• Objective - Text
• Inclusion-Exclusion - Text
• Time and Events – Table
• Study Phase - Options
• Logo – Image

D. Further, the creation module is configured for creating the object elements by selecting the created content elements, wherein the object elements are the instances of the content elements. In the below given table 1, three object elements are created for the “Inclusion-Exclusion” content elements. Further, the object elements can also be created manually.
Content Element Object Element ID Data
Inclusion-Exclusion OE-InclExcl-1 Inclusion criteria:
•Between the ages of 18 and 60
•Willing and able to give informed consent
Exclusion criteria:
•Patients who do not meet criteria for the disorder that is being studied
•Women who are pregnant or breast-feeding
OE-InclExcl-2 Inclusion criteria:
•T-cell count greater than 200
•Willing and able to sign informed consent form
•Viral load greater than 10,000 copies
Exclusion criteria:
•Active opportunistic infection
•Women who are pregnant or breastfeeding
•Any vaccination within the past month
OE-InclExcl-3 Inclusion criteria:
•Must be between the age of 40-65
•Must be diagnosed as having diabetes type 2 for at-least 2 years
•Must have HbA1c above 8% (HbA1c is called Glycosylated hemoglobin and it measures long terms sugar levels )
Exclusion criteria:
•Must not be taking any insulin treatments
•Must not have any cardio-vascular events such as stroke, myocardial infarction

Table 1: Representing the, three object elements created for the “Inclusion-Exclusion” content elements.

E. After creation of the content elements and the object elements by the creation module, an another processor-enabled programmed module i.e., uploading module, uploads the eProtocol document template which is to be used for authoring having content element tags.
F. Upon uploading of the document template i.e., eProtocol document template, the selection module selects the particular study for which the documents has to be authored and further selects the eProtocol document template which is previously uploaded in the master repository for authoring process.
G. The receiving module, upon selecting the study and its corresponding document template i.e., eProtocol document template, receives the metadata information which is shown below:
Header - Multiple dose study to investigate Safety, Tolerability, Pharmacokinetic and Pharmacodynamic profiles of TU-189b
Footer - Phase 1 trial
Title - Multiple dose study to investigate Safety, Tolerability, Pharmacokinetic and Pharmacodynamic profiles of TU-189b
Sponsor Address- XYZ Corporation, City M
Logo - Upload Sponsor Logo
H. Upon receiving the metadata information, the content elements which were created previously for authoring the eProtocol document are displayed in the displayed panel in a tree view. From the displayed content elements, the importing module imports and assembles the appropriate or required content elements based upon that, the instances of the imported and assembled content elements i.e., the object elements are further displayed and imported by the importing module for authoring the clinical trial document. In this exemplary embodiment of the present invention, choosing “Inclusion-Exclusion” as a content element will bring up the corresponding object elements which are stored in the master repository for authoring the clinical trial document i.e., the eProtocol document.
I. Upon completion of the authoring process of the eProtocol document, the authored eProtocol document is generated in a desired format ie., Microsoft Word format, an Adobe Portable Format (PDF) or combination thereof.
The illustrations of arrangements described herein are intended to provide a general understanding of the structure of various embodiments, and they are not intended to serve as a complete description of all the elements and features of methods and system that might make use of the components described herein.
The methodology and techniques described with respect to the present invention can be performed using a computer-implemented system or other computing device within which a set of instructions, when executed, may cause the said computer-implemented system to perform any one or more of the methodologies discussed above. The said computer-implemented system may include a processor embedded within the said computer-implemented system which is configured for executing the said programmed instructions or the said set of instructions. The said computer-implemented system is configured from different modules; each module is configured for executing programmed instructions or set of instruction to perform a particular task. According to the embodiments of the present invention, the computer-implemented system may also operate as a standalone device. In some embodiments, the said computer-implemented system may be connected (e.g., using a network) to other computing devices. In a networked deployment, the computer-implemented system may operate in a client-server terminology. The said computer-implemented system may be configured to work along with a server computer, a client user computer, a personal computer (PC), a tablet PC, a laptop computer, a desktop computer, a control system, machine capable of executing a set of instructions (sequential or otherwise) that specify actions to be taken by that machine.
In accordance with various embodiments of the present invention, the computer-implemented methods described herein are intended for operation as software programs running on a computer processor – [processor embedded within the said computer-implemented system].
Although the invention has been described in terms of specific embodiments and applications, persons skilled in the art can, in light of this teaching, generate additional embodiments without exceeding the scope or departing from the spirit of the invention described herein.

We Claim:
1. A computer-implemented method for authoring clinical trial documents, characterized by assembling the componentized re-usable content elements and its corresponding object elements, wherein the content elements and the object elements are stored in matrix based repositories, the method comprising the steps of:

a. creating the content elements by selecting data type and data elements having associated data for providing information related to the selected data type and storing the created content elements in a first matrix based repositories;

b. creating the object elements by selecting appropriate content elements and storing the created object elements in a second matrix based repository, wherein the object elements are instances of their corresponding content elements;

c. uploading one or more XML based document template having content element tags;

d. selecting at least one study or clinical trial and the suitable document template corresponding to the selected study or the clinical trial;

e. receiving a metadata information of the clinical trial document in the selected document template; and

f. importing and assembling the appropriate content elements and its corresponding object elements in order to result in an authored clinical trial document.

2. The method as claimed in claim 1, wherein the document includes Clinical Protocol, Clinical Study Report (CSR), Clinical Investigator Brochure, Statistical Analysis Plan (SAP), Data Management Plan (Data Management Plan), Trial Summary or any other clinical trial related document.

3. The method as claimed in claim 1, wherein the content elements provide information on the data type such as text, images, tables, options or combination thereof.

4. The method as claimed in claim 1, wherein the document templates are XML base file tagged to content elements.

5. The method as claimed in claim 1, wherein the metadata information of the clinical trial document is selected from the group comprising header and footer information, author name, version, document title and any logos.

6. The method as claimed in claim 1, wherein the method includes an optional step for selecting the content elements from a tree view.

7. A system for authoring clinical trial documents, characterized by assembling the componentized re-usable content elements and its corresponding object elements, wherein the content elements and the object elements are stored in matrix based repositories, the system comprises of:

a. a creation module configured for creating the content elements by selecting data type and data elements having associated data for providing information related to the selected data type and further configured for creating object elements by selecting appropriate content elements;

b. a master repository comprising of first and second matrix based repository, wherein the master repository is configured for storing the created content elements and its corresponding object elements in the first and the second matrix based repository respectively, wherein the object elements are instances of their corresponding content elements;

c. an uploading module configured for uploading one or more XML based document template having content element tags;

d. a selection module configured for selecting at least one study or clinical trial and the suitable document template corresponding to the selected study or the clinical trial;

e. a receiving module configured for receiving a metadata information of the clinical trial document in the selected document template; and

f. an importing module configured for importing and assembling the appropriate content elements and its corresponding object elements in order to result in an authored clinical trial document.

8. The system as claimed in claim 7, wherein the document includes Clinical Protocol, Clinical Study Report (CSR), Clinical Investigator Brochure, Statistical Analysis Plan (SAP), Data Management Plan (Data Management Plan), Trial Summary or any other clinical trial related document.

9. The system as claimed in claim 7, wherein the content elements provide information on the data type such as text, images, tables, options or combination thereof.

10. The system as claimed in claim 7, wherein the document templates are XML base file tagged to content elements.

11. The system as claimed in claim 7, wherein the said metadata information of the clinical trial document is selected from the group comprising header and footer information, author name, version, document title and any logos.