WO2003081488A1

WO2003081488A1 - Management system for conducting a procedure and method for managing a purchase by a customer

Info

Publication number: WO2003081488A1
Application number: PCT/AU2003/000378
Authority: WO
Inventors: Celia Rachel Hicks; James Williams; Helen Wray; David Cox; Elizabeth Mccall
Original assignee: Argus Biomedical Pty Ltd
Priority date: 2002-03-27
Filing date: 2003-03-27
Publication date: 2003-10-02
Also published as: AUPS141202A0

Abstract

A management system for conducting a procedure (10) comprising: client interface means (16) for providing the input of information from a client (12) and the supply of information to the client (12) in relation to the procedure; information acquisition means for acquiring prescribed information about a prospective candidate for the procedure via the client interface means; information storage means (60) for receiving and storing the acquired prescribed information about the candidate; information processing means for assessing the acquired prescribed information and determining the suitability of the candidate for the procedure on the basis of the prescribed information; and administrative means (14) for monitoring the conduct of the procedure in relation to the affected candidate and prompting the client for reporting prescribed information in relation to the procedure of the approved candidate; wherein the information acquisition means provides to the client a plurality of candidate processes for acquiring the prescribed information in a controlled and regulated manner and wherein the administrative means provides a plurality of administrative processes for administering and reporting on the prescribed information in a controlled and regulated manner.In a second embodiment of the invention there is a method for managing a purchase by a customer comprising the steps of: acquiring prescribed information regarding the customer's purchase; assessing the prescribed information to determine suitability of purchase; supplying product or service the subject of the purchase to the customer; and requesting customer provide prescribed reports, subsequent to supply, regarding suitability of purchase and details of any adverse events relating to purchase.

Description

"Management System for Conducting a Procedure and Method for

Managing a Purchase by a Customer"

Field of the Invention

This invention relates to a management system for conducting a procedure, and a method for managing a purchase by a customer. The invention has particular, but not exclusive, utility in the management of clinical trials or other medical interventions for new medical products where the participating medical professionals are located remotely of each other.

Throughout the specification, unless the context requires otherwise, the word "comprise" or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated integer or group of integers but not the exclusion of any other integer or group of integers. Additionally, the word "procedure" will be understood to include clinical trials and medical interventions and any data collection, monitoring and management of any clinical information for any medical intervention or clinical trial.

Background Art

The following discussion of the background to the invention is intended to facilitate an understanding of the present invention. However, it should be appreciated that the discussion is not an acknowledgement or admission that any of the material referred to was published, known or part of the common general knowledge in Australia as at the priority date of the application.

A government body delegated the task of approving a new medical technology the subject of a clinical trial will require reports and access to complete data sets upon which to base its decision. Similarly, the body administering the clinical trial will need reports upon which to make strategic decisions. In order to produce such reports, large amounts of data pertaining to the clinical trial will need to be recorded. This data recordal process is easier to maintain and police when the medical professionals and other participants involved in the clinical procedure are located in a discrete area central to the clinical trial's or medical intervention's administrative body. However, modern clinical trials and medical interventions may involve medical professionals and other participants from all over the world. This increases the administrative complexity and cost associated with the data recordal process and increases the risk that important data may not be recorded at all.

Further, in this scenario, the risk that important data may not be recorded at all is increased due to the additional complexity involved in encouraging the medical professionals and other participants involved in the clinical trial to conduct follow- up examinations and file follow-up reports.

Also adding to the administrative complexity of clinical trials is the common use of multiple data sources for the storage of information regarding a clinical trial and the need for data security.

Similar problems to those already mentioned also apply to processes involved in the monitoring of outcomes of other medical interventions.

It is an object of the present invention, as it relates to procedures, to alleviate at least some, if not all, of the above administrative problems associated with the conduct of a clinical trial or complex medical intervention. It is an alternative object of the present invention, as it relates to the purchase by a customer, to facilitate the determination by the supplier that the purchase is suitable for the customer.

Disclosure of the Invention

In accordance with a first aspect of the present invention, there is provided a management system for a procedure comprising: client interface means for providing the input of information from a client and the supply of information to the client in relation to the procedure;

information acquisition means for acquiring prescribed information about a prospective candidate for the procedure via the client interface means;

information storage means for receiving and storing the acquired prescribed information about the candidate;

information processing means for assessing the acquired prescribed information and determining the suitability of the candidate for the procedure on the basis of the prescribed information; and

administrative means for monitoring the conduct of the procedure in relation to the affected candidate and prompting the client for reporting prescribed information in relation to the procedure of the approved candidate,

wherein the information acquisition means provides to the client a plurality of candidate processes for acquiring the prescribed information in a controlled and regulated manner;

and wherein the administrative means provides a plurality of administrative processes for administering and reporting on the prescribed information in a controlled and regulated manner.

The client interface means may change for customers with specific needs or for clinical trials with several protocols, criteria for assessment or treatment modalities. This will include options for different "skins" or treatment screens to suit different trials or protocols within the one web-site.

Preferably, the information processing means further communicates the rejection or approval of the prospective candidate to the client via the client interface means. Preferably, the information processing means automatically assesses the acquired prescribed information against a set of predetermined conditions.

More preferably, the information processing means refers the prescribed information to an assessor for manual assessment if the prescribed information does not satisfy the predetermined conditions.

Alternatively, the information processing means assesses the acquired prescribed information by referring the prescribed information to an assessor for manual assessment.

Preferably, the management system includes invoicing means for issuing an invoice to a party specified by the client on confirmation by the client that the candidate will participate in the procedure.

Preferably, alerts are sent to the client via the client interface means on event of predefined conditions.

More preferably, the predefined conditions include:

refusal of a candidate after assessment;

acceptance of a candidate after assessment;

expiry of a candidate's designated date for surgical operation or commencement of protocol;

expiry of a predetermined time period from a candidate's designated date for surgical operation or commencement of protocol;

satisfaction of conditions associated with a termination event in respect of a candidate; and

attending to a request for assistance made by the client. Still more preferably, the client completes an initial report in respect of a candidate using the client interface means and submits the initial report to the administrative means upon receiving an alert that the designated date for surgical operation or commencement of protocol as applies to that candidate has expired and an initial report for that candidate has not been completed and submitted to the administrative means.

Still more preferably, the client completes a follow-up report in respect of a candidate using the client interface means and submits the follow-up report to the administrative means upon receiving an alert that a predetermined time period from a candidate's designated date for surgical operation or commencement of protocol has expired and the required follow-up report has not been completed and submitted to the administrative means.

Still more preferably, the client completes a final report in respect of a candidate using the client interface means and submits the final report to the administrative means upon receiving an alert that a termination event in respect of the candidate has been satisfied and the required final report has not been completed and submitted to the administrative means.

Preferably, the client can communicate, via the client-interface means, with an administrator, via the administrator means.

More preferably, the method of communication involves the client completing a form and the administrator annotating or replying to the form. More preferably, the method of communication is e-mail.

More preferably, the method of communication is a bulletin board.

Preferably, the information processing means and administrative means are integral to each other. In accordance with a second aspect of the present invention, there is a client station for a management system for conducting a procedure having a server station comprising:

information storage means;

information processing means; and

administrative means,

wherein the client station comprises:

client interface means for providing the input of information from a client and the supply of information to the client in relation to the procedure;

the information acquisition means providing to the client a plurality of candidate processes for acquiring the prescribed information in a controlled and regulated manner; and

information transmittal means for transmitting the acquired prescribed information about the candidate to the server station,

where the server station stores the acquired prescribed information about the candidate in the information storage means; the information processing means assesses the prescribed information and determines the suitability of the candidate for the procedure on the basis of the prescribed information; and the administrative means monitors the conduct of the procedure in relation to the affected candidate, prompts the client for reporting prescribed information in relation to the procedure of the approved candidate and provides a plurality of administrative processes for administering and reporting on the prescribed information in a controlled and regulated manner. Preferably, the client interface means receives alerts sent to the client station by the server station on event of predefined conditions.

Preferably, the client interface means includes report entry means for completing a report and the information transmittal means includes report transmittal means for transmitting the completed report.

Preferably, the client station includes communication means for communicating with the administrative means.

More preferably, the communication means provides for e-mail communication with the administrative means.

Alternatively, the communication means is a bulletin board.

In accordance with a third embodiment of the invention there is a server station for a management system for conducting a procedure having a client station including information transmittal means, the server station comprising:

information storage means for receiving and storing acquired prescribed information about a candidate transmitted by the information transmittal means;

wherein the administrative means provides a plurality of administrative processes for administering and reporting on the prescribed information in a controlled and regulated manner. Preferably, the client station further includes a client interface means and the information processing means further communicates the rejection or approval of the prospective candidate to the client via the client interface means.

Preferably, the information processing means automatically assesses the acquired prescribed information against a set of predetermined conditions.

Preferably, the server station includes invoicing means for issuing an invoice to a party.

Preferably, the administrative means sends alerts to the client via the client interface means on event of predefined conditions.

More preferably, the predefined conditions include:

refusal of a candidate after assessment;

acceptance of a candidate after assessment;

satisfaction of conditions associated with a termination event in respect of a candidate; and attending to a request for assistance made by a client.

Still more preferably, the administrative means receives a report from the information transmittal means upon after sending an alert to the client on at least one of the following:

expiry of a predetermined time period from a candidate's designated date for surgical operation or commencement of protocol; and

satisfaction of conditions associated with a termination event in respect of a candidate.

Preferably, an administrator can communicate, via the administrative means, with a client, via the client interface means.

More preferably, the method of communication involves receiving a form from the client and annotating or replying to the form.

More preferably, the method of communication is e-mail.

More preferably, the method of communication is a bulletin board.

In yet a fourth embodiment of the invention, there is provided a method for managing a purchase by a customer comprising:

acquiring prescribed information regarding the customer's purchase;

assessing the prescribed information to determine suitability of purchase;

supplying product or service the subject of the purchase to the customer; and requesting customer provide prescribed reports, subsequent to supply, regarding suitability of purchase and details of any adverse events relating to purchase.

Preferably, the method further includes the step of requesting the customer to confirm purchase if the assessment of the prescribed information indicates that the purchase is suitable for the customer and where the step of supplying the product or service the subject of the purchase is attended to upon confirmation by the customer.

Preferably, the method further includes the step of suggesting alternative purchases to the customer based on assessment of the prescribed information.

Preferably, the step of assessing the prescribed information is performed automatically and if the automatic assessment cannot properly assess the suitability of the purchase the prescribed information is provided to an administrator for manual assessment.

Preferably, the method further includes the step of allowing the customer to request assistance in relation to the purchase.

Preferably, the method further includes the step of analysing the prescribed information, prescribed reports and any adverse events reported by customers.

Brief Description of the Drawings

The present invention will now be described with reference to the accompanying drawings, in which:-

Figure 1 is a representational diagram of the invention;

Figure 2 is a flow-chart of the Surgeon portal;

Figure 3a is a first screen capture showing the type of prescribed information required by a request; Figure 3b is a second screen capture showing the type of prescribed information required by a request.

Best Mode(s) for Carrying Out the Invention

In accordance with the present invention there is a management system for a procedure 10, the procedure in the present invention being a clinical trial or medical intervention. The management system for conducting clinical trials or medical interventions 10 is initiated by a medical professional 12, or their representative who would be identified as such, who accesses a clinical trial or medical intervention web-site 14 via a web-browser 16 running on a first computer 18.

The clinical trial or medical intervention web-site 14 requests the medical professional 12 to identify themselves and enter in a valid password. Once a valid identification and password has been entered the medical professional 12 can access other functions of the system 10. The combination of a valid identification and password determines the level of access that the medical professional 12 has to the system 10, if any.

After entering a valid identification and password, the medical professional 12 enters the Surgeon portal 20. The Surgeon portal 20 allows the medical professional 12 to perform any of the following tasks:

• create a request 22 to include a patient 23 in the clinical trial or medical intervention;

• lodge a request 22 to include a patient 23 in the clinical trial or medical intervention;

• confirm a request 22 to include a patient 23 in the clinical trial or medical intervention;

• review alerts; • submit a medical report;

• request assistance;

• record an adverse event;

• generate reports;

• view materials from the administrator; and

• contribute to a bulletin board.

Creating a Request

If the medical professional 12 chooses to create a request 22, the web-browser 18 loads a set of prescribed forms 24 from the clinical trial or medical intervention web-site 14. The prescribed forms 24 request certain medical details about the patient 23. An example prescribed form 24 is shown in Figure 3. The information entered into the prescribed forms 24 comprise the request 22.

Lodging a Request

Once all the mandatory information required by the prescribed forms 24 has been completed the medical professional 12 may lodge the request 22 with the clinical trial or medical intervention web site 14. If the request 22 is lodged, the request's 22 status is updated from "Incomplete" to "In Progress" and the request 22 is stored in a database 60. If the request 22 is not lodged, the request's 22 status retains the value "Incomplete" and is stored in a database for further information additions.

Once lodged, an automatic processor 26 processes the request 22. The automatic processor 26 assesses the information that forms the request 22. If this information satisfies the predetermined conditions for inclusion into the clinical trial or medical intervention, the request 22 is accepted. Upon acceptance the request's 22 status is changed to "Processed".

If the information does not satisfy the predetermined conditions for inclusion into the clinical trial or medical intervention, the request 22 is forwarded to an administrator 28a for manual assessment 30. Forwarding a request 22 for manual assessment 30 results in the request's 22 status being changed to "Awaiting Processing".

During manual assessment 30, the clinical administrator 50 reviews the information that forms the request 22 and makes a decision on whether to include the patient 23 in the clinical trial or medical intervention or not. If the clinical administrator 50 decides to exclude the patient 23 from the clinical trial or medical intervention, the request's 22 status is set to "Returned". A note 32 may accompany the "returned" request 22 detailing the reason(s) the clinical administrator 50 has decided to exclude the patient 23 from the clinical trial or medical intervention. If the medical professional 12 does not act on a "returned" request 22 within a short time frame, the request's 22 status may be reset to "Incomplete".

Alternatively, the clinical administrator 50 may decide to include the patient 23 in the clinical trial or medical intervention provided that certain conditions are met or that the patient 23 be subjected to certain protocols or products only.

If, as a result of manual assessment, the request 22 is accepted or conditionally accepted (and the conditions satisfied), the request's 22 status is updated to "Processed".

When a request's 22 status is first changed to "Processed", the web-site 14 notifies the medical professional 12 that the patient 23 the subject of the request 22 has been considered acceptable for inclusion in the clinical trial or medical intervention via an alert (discussed further below). This notification will also specify the product or protocol (as appropriate) that is to apply in relation to the patient 23. Confirming a Request

Upon receipt of a notification that a patient 23 the subject of a request 22 has been considered acceptable for inclusion in the clinical trial or medical intervention, the medical professional 12 will be asked to confirm the patient's inclusion. The medical professional 12 may also be required to provide a purchase order number and specify a creditor 27 an invoice should be sent to depending on the subject matter of the clinical trial or medical intervention.

Upon confirmation of the patient's inclusion by the medical professional and specification of the purchase order number and invoice creditor 27 (if applicable), the request's 22 status will be set to "Accepted".

If the medical professional 12 is required to provide a purchase order number and specify a creditor 27 an invoice should be sent to, the clinical trial or medical intervention web-site 14 will transfer this information to a financials program 34, such as SCALA™. The financials program 34, will then generate an appropriate invoice 36 and send it to the specified creditor 27. Upon sending the invoice 36, the request's 22 status is set to "Awaiting Payment".

The financials program 34 processes payment of an invoice 36. Once invoice payment processing has been completed the clinical trial or medical intervention web-site 14 interacts with a production control system 38 to allocate a serial number to the product/protocol the subject of the invoice 36 (as applicable). This serial number is then associated with the accepted request 22. The product/protocol is then conveyed or shipped (as appropriate) to the medical professional 12 and the request's 22 status updated to "Shipped". This also initiates the reporting sequence and auto-prompt mechanisms (discussed below).

Reviewing alerts

When a request's 22 status is set to a particular value, such as "Returned" and "Processed", an alert appropriate to the request's status will be generated and linked to the request 22. Those alerts appropriate to the medical professional 12 are arranged in lists and displayed to the medical professional 12 upon access to the Surgeon portal 20 (and thus are not a function that must be selected by the medical professional 12 per se). The alerts facilitate or remind the medical professional 12 about actions that need to be taken or events that have occurred.

The medical professional 12 may only view alerts relating to requests 22 made by him/her.

Submitting a Medical Report

Throughout the clinical trial or medical intervention a series of medical reports 40 will be requested from the medical professional 12. These reports 40, and the process by which the medical professional 12 is requested to provide these reports 40, are discussed below.

Once a request 22 has achieved the status of "Shipped", the clinical trial or medical intervention web-site 14 will review the request 22 to determine whether a date has been set for surgical operation or commencement of the protocol (as appropriate to the clinical trial or medical intervention). If so, the medical professional 12 will be sent an alert requesting that he/she complete an initial report 40a and submit it to the clinical trial or medical intervention web-site 14 as soon as possible.

To complete and submit the initial report 40a, the medical professional 12 requests the web-browser 16 to load the Surgery Report form 42 from the clinical trial or medical intervention web-site 14. The medical professional 12 then enters the required information into the Surgery Report form 42, attaching additional documentation, such as PG or MPEG files, where appropriate or necessary. The information that comprises the completed Surgery Report form 42 is submitted to the clinical trial or medical intervention web-site 14 for storage in database 60.

If the request 22 does not contain a set date for surgical operation or commencement of the protocol (as appropriate to the clinical trial or medical intervention), the clinical trial or medical intervention web-site 14 will monitor the request 22. When the request 22 does contain a set date for surgical operation or commencement of the protocol, the procedure stated in the previous two paragraphs is activated.

Subsequent to the date set for surgical operation or commencement of the protocol the medical professional 12 will be asked at periodic intervals to provide follow-up reports 40b by way of an alert. To complete and submit a follow-up report 40b, the medical professional 12 requests the web-browser 16 to load the Follow-up Report form 44 from the clinical trial or medical intervention web-site 14. The medical professional 12 then enters the required information into the Follow-up Report form 44, attaching additional documentation, such as PG or MPEG files, where appropriate or necessary. The information that comprises the completed Follow-up Report form 44 is submitted to the clinical trial or medical intervention web-site 14 for storage in database 60.

The medical professional 12 may also be requested to provide a final report 40c by way of an alert upon satisfaction of a termination event. A termination event may be removal of the medical device the subject of the clinical trial or medical intervention from the patient 23, death of the patient 23, or completion of the protocol the subject of the clinical trial or medical intervention.

To complete and submit a final report 40c, the medical professional 12 requests the web-browser 16 to load the Final Report form 46 from the clinical trial or medical intervention web-site 14. The medical professional 12 then enters the required information into the Final Report form 46, attaching additional documentation, such as JPG or MPEG files, where appropriate or necessary. The information that comprises the completed Final Report form 46 is submitted to the clinical trial or medical intervention web-site 14 for storage in database 60.

Requesting Assistance

If the medical professional 12 requests assistance, the web-browser 16 loads the Request for Assistance form 48a from the clinical trial or medical intervention web-site 14. The medical professional 12 then enters the required information to specify the type of assistance required into the Request for Assistance form 48a. Once completed, the Request for Assistance form 48a is submitted to the clinical trial or medical intervention web-site 14 for forwarding to a clinical administrator 50.

A request for assistance can also be made by clicking the Assistance Request button on any page of the clinical trial or medical intervention web-site 14. This causes the web-site 14 to interface with the medical professional's 12 email program, sending an email to the clinical administrator 50 detailing the Request ID and Surgeon name.

The clinical administrator 50 reviews the Request for Assistance form 48a or email and appends his or her suggestions for assistance thereto and re-sends it to the clinical trial or medical intervention web-site 14 or replies to the email for return to the medical professional 12. The medical professional 12 then receives an alert or email advising that his/her request for assistance has been tended to, the alert also providing a link to the revised Request for Assistance form 48b.

If the medical professional 12 wishes to respond or needs to clarify the clinical administrator's 50 response, the medical professional 12 may append his or her comments to the revised Request for Assistance form 48b and re-submit it. This cycle of communication between medical professional 12 and clinical administrator 50 may continue as described above until the request for assistance has been satisfied.

Details of all Requests for Assistance forms 48 are stored in database 60.

The medical professional 12 may only view requests for assistance made by him/her. Recording an Adverse Event

If the medical professional 12 chooses to report an adverse event, the web- browser 16 loads the Adverse Event form 52 from the clinical trial or medical intervention web-site 14. The medical professional 12 then enters the required information into the Adverse Event form 52, adding attachments such as JPG or MPEG files where appropriate or necessary. The information that comprises the completed Adverse Event form 52 is then submitted to the clinical trial or medical intervention web-site 14 for storage. The clinical administrator 50 is also alerted to the presence of the Adverse Event form 52 and is required to review the Adverse Event form 52.

Generating Reports

The medical professional 12 may view reports regarding the clinical trial or medical intervention as a whole and/or those patients 23 he or she included in the clinical trial or medical intervention. These reports may take the form of statistical analyses or individual histories and records or a combination of the two.

A medical professional 12 cannot view a report regarding patients 23 included in the clinical trial or medical intervention by another medical professional 12.

The management system for conducting clinical trials or medical interventions 10 can also be initiated by an administrator 28b who access the clinical trial or medical intervention web-site 14 via a web-browser 16 running on a second computer 54. This second computer 54 may also host the clinical trial or medical intervention web-site 14.

In this arrangement, the clinical trial or medical intervention web-site 14 requests the administrator 28b to identify themselves and enter in a valid password. Once a valid identification and password has been entered the administrator 28b can access other functions of the system 10. The combination of a valid identification and password determines the level of access that the administrator 28b has to the system 10. After entering a valid identification and password, the administrator 28b enters the Administration portal 56. The Administration portal 56 may allow the administrator 28b to perform the following tasks depending on their level of access:

• Reviewing alerts;

• Review surgeon details;

• Assume the identity of a medical professional 12; and

• Generate reports

Reviewing Alerts

When a request's 22 status is set to a particular value, such as "Awaiting Processing" and "Awaiting Payment", an alert appropriate to the request's status will be generated and linked to the request 22. Those alerts appropriate to administration are arranged in lists and displayed to the administrator 28b upon access to the Administration portal 56 (and thus are not a function that must be selected by the administrator 28b per se). The alerts facilitate or remind the administrator 28b about actions that need to be taken or events that have occurred.

Review surgeon details

Surgeon details are kept for the purposes of reimbursement applications, country participation, or patient monitoring. Surgeon details consist of Surgeon's name, affiliations and accreditation status, practice rooms and practice focus or any other relevant information. The clinical trial or medical intervention web-site can e-mail information to all clients.

Assuming identity of medical professional

An administrator 28b may, if provided with this level of access, assume the identity of a medical professional 12. The administrator 28b may then perform those tasks accessible from the Surgeon portal 20 that the medical professional 12 whose identity has been assumed may perform. This includes editing the prescribed information recorded in relation to a patient 23 the medical professional 12 requested be included in the clinical trial or medical intervention.

Generating Reports

An administrator 28b may generate the same reports as a medical professional 12 can (see above). However, the administrator 28b is not limited in the patient details that he or she may include in the reports.

Further the administrator 28b may export information stored on the clinical server web-site 14 or database 60 to another computer for analysis or further processing.

View Materials From the Administrator

The web-site 14 performs the task of informing the medical professional 12 of clinical results of a combined nature for the full data set of the product and also as a reporting tool for medical professionals 12 individual cases. These reports may be analysed by relevant clinical staff and uploaded to the web-site 14 by the administrator 28b.

Contribute to a Bulletin Board

The Bulletin Board may be used to announce changes to protocols, medication changes, surgical procedure changes or it may be used as an information exchange between medical professional 12 and administrators 28b and 50. This exchange is monitored by the administrator 28b with the ability for identifying information to be deleted.

It should be appreciated by the person skilled in the art that the invention is not limited to the embodiment described above. In particular, a request 22 may be processed manually by an administrator 28b rather than automatically by the automatic processor 26. In y§t a further embodiment, the clinical trial or medical processed manually by an administrator 28b rather than automatically by the automatic processor 26. In yet a further embodiment, the clinical trial or medical intervention web-site 14 provides functionality to generate the invoice 36 and send it to the specified creditor 27 in place of the financials program 34. In this further embodiment, the financials program 34 may not be necessary.

Claims

The claims defining the invention are as follows:

1. A management system for conducting a procedure comprising:

2. A management system for conducting a procedure according to claim 1 , where the information processing means further communicates the rejection or approval of the prospective candidate to the client via the client interface means.

3. A management system for conducting a procedure according to either claim 1 or claim 2, where the information processing means automatically assesses the acquired prescribed information against a set of predetermined conditions.

4. A management system for conducting a procedure according to claim 3, where the information processing means refers the prescribed information to an assessor for manual assessment if the prescribed information does not satisfy the predetermined conditions.

5. A management system for conducting a procedure according to either claim 1 or claim 2, where the information processing means assesses the acquired prescribed information by referring the prescribed information to an assessor for manual assessment.

6. A management system for conducting a procedure according to any preceding claim, further including invoicing means for issuing an invoice to a party specified by the client on confirmation by the client that the candidate will participate in the procedure.

7. A management system for conducting a procedure according to any preceding claim, where alerts are sent to the client via the client interface means on event of predefined conditions.

8. A management system for conducting a procedure according to claim 7 wherein the predefined conditions include:

refusal of a candidate after assessment;

acceptance of a candidate after assessment;

expiry of a predetermined time period from a candidate's designated date for surgical operation or commencement of protocol; satisfaction of conditions associated with a termination event in respect of a candidate; and

attending to a request for assistance made by the client.

9. A management system for conducting a procedure according to claim 8, where the client completes an initial report in respect of a candidate using the client interface means and submits the initial report to the administrative means upon receiving an alert that the designated date for surgical operation or commencement of protocol as applies to that candidate has expired and an initial report for that candidate has not been completed and submitted to the administrative means.

10. A management system for conducting a procedure according to claim 8 or claim 9, where the client completes a follow-up report in respect of a candidate using the client interface means and submits the follow-up report to the administrative means upon receiving an alert that a predetermined time period from a candidate's designated date for surgical operation or commencement of protocol has expired and the required follow-up report has not been completed and submitted to the administrative means.

11. A management system for conducting a procedure according to any one of claims 8 to 10, where the client completes a final report in respect of a candidate using the client interface means and submits the final report to the administrative means upon receiving an alert that a termination event in respect of the candidate has been satisfied and the required final report has not been completed and submitted to the administrative means.

12. A management system for conducting a procedure according to any preceding claim, where the client can communicate, via the client-interface means, with an administrator, via the administrator means.

13. A management system for conducting a procedure according to claim 12, where the method of communication involves the client completing a form and the administrator annotating or replying to the form.

14. A management system for conducting a procedure according to claim 12, where the method of communication is e-mail.

15. A management system for conducting a procedure according to claim 12, where the method of communication is a bulletin board.

16. A management system for conducting a procedure according to any preceding claim, where the information processing means and administrative means are integral to each other.

17. A client station for a management system for conducting a procedure having a server station comprising:

information storage means;

information processing means; and

administrative means,

wherein the client station comprises:

the information acquisition means providing to the client a plurality of candidate processes for acquiring the prescribed information in a controlled and regulated manner; and information transmittal means for transmitting the acquired prescribed information about the candidate to the server station,

where the server station stores the acquired prescribed information about the candidate in the information storage means; the information processing means assesses the prescribed information and determines the suitability of the candidate for the procedure on the basis of the prescribed information; and the administrative means monitors the conduct of the procedure in relation to the affected candidate, prompts the client for reporting prescribed information in relation to the procedure of the approved candidate and provides a plurality of administrative processes for administering and reporting on the prescribed information in a controlled and regulated manner.

18. A client station according to claim 16, where the client interface means receives alerts sent to the client station by the server station on event of predefined conditions.

19. A client station according to claim 16 or claim 17, where the client interface means includes report entry means for completing a report and the information transmittal means includes report transmittal means for transmitting the completed report.

20. A client station according to any one of claims 16 to 18, further including communications means for communicating with the administrative means.

21. A client station according to claim 19, where the communication means provides for e-mail communication with the administrative means.

22. A client station according to claim 20, where the communication means is a bulletin board.

23. A server station for a management system for conducting a procedure having a client station including information transmittal means, the server station comprising: information storage means for receiving and storing acquired prescribed information about a candidate transmitted by the information transmittal means;

administrative means for monitoring the conduct of the procedure in relation the affected candidate and prompting the client for reporting prescribed information in relation to the procedure of the approved candidate,

wherein the administrative means provides a plurality of administrative processes for administering and reporting on the prescribed information in a controlled and regulated manner.

24. A server station according to claim 22, where the client station further includes a client interface means and the information processing means further communicates the rejection or approval of the prospective candidate to the client via the client interface means.

25. A server station according to claim 22 or 23, where the information processing means automatically assesses the acquired prescribed information against a set of predetermined conditions.

26. A server station according to claim 24, where the information processing means refers the prescribed information to an assessor for manual assessment if the prescribed information does not satisfy the predetermined conditions.

27. A server station according to claim 22 or 23, where the information processing means assesses the acquired prescribed information by referring the prescribed information to an assessor for manual assessment.

28. A server station according to any one of claims 22 to 26, further including invoicing means for issuing an invoice to a party.

29. A server station according to any one of claims 22 to 27, where the administrative means sends alerts to the client via the client interface means on event of predefined conditions.

30. A server station according to claim 28, where the predefined conditions include:

refusal of a candidate after assessment;

acceptance of a candidate after assessment;

attending to a request for assistance made by a client.

31. A server station according to claim 29, where the administrative means receives a report from the information transmittal means upon after sending an alert to the client on at least one of the following:

expiry of a predetermined time period from a candidate's designated date for surgical operation or commencement of protocol; and satisfaction of conditions associated with a termination event in respect of a candidate.

32. A server station according to any one of claims 22 to 30, where an administrator can communicate, via the administrative means, with a client, via the client interface means.

33. A server station according to claim 31 , where the method of communication involves receiving a form from the client and annotating or replying to the form.

34. A server station according to claim 31 where the method of communication is e-mail.

35. A server station according to claim 31 , where the method of communication is a bulletin board.

36. A method for managing a purchase by a customer comprising:

acquiring prescribed information regarding the customer's purchase;

assessing the prescribed information to determine suitability of purchase;

supplying product or service the subject of the purchase to the customer; and

requesting customer provide prescribed reports, subsequent to supply, regarding suitability of purchase and details of any adverse events relating to purchase.

37. A method for managing a purchase by a customer according to claim 34, further including the step of requesting the customer to confirm purchase if the assessment of the prescribed information indicates that the purchase is suitable for the customer and where the step of supplying the product or service the subject of the purchase is attended to upon confirmation by the customer.

38. A method for managing a purchase by a customer according to claim 34 or claim 35, further including the step of suggesting alternative purchases to the customer based on assessment of the prescribed information.

39. A method for managing , a purchase by a customer according to any one of claims 34 to 36, where the step of assessing the prescribed information is performed automatically and if the automatic assessment cannot properly assess the suitability of the purchase the prescribed information is provided to an administrator for manual assessment.

40. A method for managing a purchase by a customer according to any one of claims 34 to 37, including the step of allowing the customer to request assistance in relation to the purchase.

41. A method for managing a purchase by a customer according to any one of claims 34 to 38, including the step of analysing the prescribed information, prescribed reports and any adverse events reported by customers.

42. A management system for conducting a procedure substantially as described herein with reference to the drawings.

43. A client station for use in a management system for conducting a procedure substantially as described herein with reference to the drawings.

44. A server station for use in a management system for conducting a procedure substantially as described herein with reference to the drawings.

45. A method for managing a purchase by a customer substantially as described herein with reference to the drawings.