JP2013524368A5 - - Google Patents

Claims (23)

A method for managing a clinical trial,
A step trial administrator creates and manages at least one trial website and the administrator portal to exchange clinical trial documents by the trial website, the at least one computer to generate,
The at least one computer generates a trial website for each trial to be managed, and the investigator is authorized to participate in the trial website , and each trial website manages the trial document. Each trial website has a separate file for storage of data supporting the relevant trial that is accessible to the relevant trial administrator and each authorized investigator. And
The at least one computer generates a doctor portal for each investigator, wherein the doctor portal is adapted to upload a document from the investigator , the document being the investigator there is related to the clinical trial is authorized to participate, the investigator is stored in a separate file of the relevant clinical trial web site is authorized to participate, the investigator through the physician portal, the trial Monitor activities and communications related to the trials the physician is authorized to participate in ,
A method characterized by comprising: The administrator portal, further lists a plurality of the investigator, and the administrator, to enable sending the invite invitation to participate in the trial in the trial physician, the method of claim 1.   The method of claim 1, wherein the administrator portal further allows the administrator to create a trial master file for an associated trial website for customization based on a template.   The physician portal further lists a plurality of trials managed by the administrator, allowing the investigator to contact the administrator about their interest in participating in a particular trial. Item 2. The method according to Item 1. The physician portal, further the investigator is it possible to determine the personal profile for access by the administrator, the process of claim 1. The physician portal, further the investigator is to allow to define the executing agency profile for access by the administrator, the process of claim 1.   The method of claim 1, wherein the physician portal further allows the investigator to access an investigational drug file associated with characteristics of the investigational drug being tested in the trial.   The method of claim 1, wherein the physician portal further allows the investigator to identify metadata and index uploaded documents.   The method of claim 1, wherein the physician portal further allows the investigator to access a current version of a mandatory document that affects the conduct of the trial in real time.   The method of claim 1, wherein the physician portal communicates a to-do list of required work items between the administrator and the investigator.   The method of claim 1, wherein the physician portal communicates a safety report related to a test drug between the administrator and the investigator. A system for managing clinical trials,
Having at least one processor and at least one memory for storing instructions, said instructions causing said at least one processor to perform the following steps when executed by said at least one processor:
Clinical trial administrator creates and manages at least one trial website, generates administrative portal to exchange the trial websites and trial documents,
Generate a clinical trial website for each trial to be managed , where the investigator is authorized to participate in each clinical trial website, and each trial website exchanges clinical trial documents with the administrator portal and The site has a separate file for storing data supporting the relevant trial that can be accessed by the relevant trial administrator and each authorized investigator,
To generate a physician portal for each investigator, should be noted, the physician portal, said has been adapted to a document is uploaded from the investigator, the document is, in the trial that is authorized the investigator to participate are those related to, the investigator is stored in a separate file of the relevant clinical trial web site is authorized to participate, by the physician portal, the investigator may, in the trial that is authorized the investigator to participate you monitor the activity and contact related,
A system characterized by that.   The system of claim 12, wherein the administrator portal lists a plurality of investigators and allows the administrator to send an invitation to invite the investigators to participate in a study.   13. The system of claim 12, wherein the administrator portal allows the administrator to create a trial master file for an associated trial website for customization based on a template.   13. The physician portal lists a plurality of trials managed by the administrator and allows the investigator to contact the administrator regarding interest in participating in a particular trial. System. The physician portal, the investigator is to allow to define a personal profile for access by the administrative system of claim 12, wherein. The physician portal, the investigator is to allow to define the executing agency profile for access by the administrative system of claim 12, wherein.   13. The system of claim 12, wherein the physician portal allows the investigator to access study drug files associated with the characteristics of the study drug being tested in the trial.   13. The system of claim 12, wherein the physician portal allows the investigator to index uploaded documents with identifying metadata based on identity and associated trial and site information. .   13. The system of claim 12, wherein the physician portal further allows the investigator to access the latest version of a required document that affects the conduct of the trial in real time.   The system of claim 12, wherein the contact includes a to-do list of required work items to be contacted between the administrator and the investigator.   The system of claim 12, wherein the physician portal communicates safety reports related to a test drug between the administrator and the investigator.   The system of claim 12, wherein the processor further executes instructions of workflow management software that implements the generating step according to a predetermined workflow order and sequence run by a template.