SYSTEMS AND METHODS FOR MANAGING CLINICAL TRIAL SITE VISIT REPORTS

1 . A clinical trial site visit management system comprising:

a database comprising a plurality of questions associated with identifiers of report types for site visits that are conducted to manage clinical trials; and

a processor capable of executing code embodied on a non-transitory computer-readable medium to cause the clinical trial site visit management system to:

responsive to receiving input representing that a site visit has been completed, determine at least one deadline for completing a site visit report for the site visit;

output a notification to an associate regarding the at least one deadline;

responsive to receiving an identifier of a report type for the site visit report, determine at least one question of the plurality of questions that is associated with the identifier and configure a user interface to include the at least one question; and

responsive to receiving an approval for the site visit report, provide the site visit report to a document management system.

2 . The clinical trial site visit management system of claim 1 , wherein the processor is further configured to store a link to the site visit report that is in the document management system.

3 . The clinical trial site visit management system of claim 1 , wherein the processor is further configured to associate at least one document with the site visit report.

4 . The clinical trial site visit management system of claim 1 , wherein the site visit report comprises electronic signatures of the associate and a reviewer.

5 . The clinical trial site visit management system of claim 1 , wherein the processor is further configured to, responsive to receiving a specified response to the at least one question, configure the user interface to prohibit receiving a response to a subsequent question to the at least one question.

6 . The clinical trial site visit management system of claim 1 , wherein the database comprises process rules associated the identifiers of report types for site visits.

7 . The clinical trial site visit management system of claim 6 , wherein the processor is further configured to, responsive to receiving a command to submit the site visit report to a reviewer, confirm that at least one of (i) the site visit report or (ii) steps for completing the site visit report, comply with a process rule associated with the identifier of the report type for the site visit report.

8 . The clinical trial site visit management system of claim 1 , wherein the processor is further configured to:

analyze a response to the at least one question to determine additional information is desirable; and

generate at least one additional question based on the response to seek the additional information.

9 . The clinical trial site visit management system of claim 1 , wherein the processor is further configured to generate an audit trail for the site visit report.

10 . The clinical trial site visit management system of claim 1 , wherein the processor is further configured to output a message to a sponsor of a clinical trial associated with the site visit, the message comprising the site visit report.

11 . The clinical trial site visit management system of claim 1 , wherein the processor is further configured to receive a schedule for the site visit prior to the site visit occurring and to output a message to the associate after the site visit was scheduled to occur, the message comprising a reminder for the associate to complete the site visit report.

12 . The clinical trial site visit management system of claim 1 , wherein, responsive to receiving the approval for the site visit report from a reviewer, the processor is further configured to:

create a portable document file (PDF) of the site visit report using a Japanese format template if a protocol associated with the site visit report is flagged; and

create the PDF of the site visit report using an English format template if the protocol associated with the site visit report is unflagged.

13 . The clinical trial site visit management system of claim 1 , wherein the processor is further configured to receive additional questions from a reviewer and configure the user interface to present the additional questions to the associate.

14 . The clinical trial site visit management system of claim 1 , wherein the database comprises a Siebel customer relationship management (CRM) database,

wherein the processor comprises a database server software application.

15 . The clinical trial site visit management system of claim 1 , wherein the at least one deadline comprises a first deadline for completing a draft of the site visit report and a second deadline for completing a final version of the site visit report.

16 . The clinical trial site visit management system of claim 1 , wherein the report types comprise:

a site selection visit (SSV) report;

a site initiation visit (SIV) report;

a site monitoring visit (SMV) report; and

a site closeout visit (COV) report.

17 . The clinical trial site visit management system of claim 1 , further comprising the document management system, the document management system being capable of creating a file comprising the site visit report and at least one document associated with the site visit report.

18 . The clinical trial site visit management system of claim 17 , where the database comprises the document management system.

19 . A computer-implemented method for managing a clinical trial, comprising:

receiving input representing that a site visit has been completed and an identifier of a report type for a site visit report about the site visit;

determining, by a computing device, at least one deadline for completing the site visit report based on a completion date of the site visit and outputting a notification to an associate about the at least one deadline;

determining, by the computing device, at least one question of a plurality of questions that is associated with the identifier and configuring a user interface to include the at least one question; and

in response to receiving an approval of the site visit report, providing the site visit report to a sponsor.

20 . The computer-implemented method of claim 19 , further comprising:

in response to receiving the approval of the site visit report,

creating a portable document file (PDF) comprising the site visit report and a collateral document;

providing the PDF file to a document management system for storage; and

storing a link to the PDF file stored in the document management system.

21 . The computer-implemented method of claim 19 , further comprising:

analyzing an answer to the at least one question and determining a subsequent question to present on the user interface based on the answer; and

confirming that at least one of (i) the site visit report or (ii) steps for completing the site visit report, comply with a process rule associated with the identifier of the report type for the site visit report.

22 . The computer-implemented method of claim 19 , wherein outputting the notification to the associate about the at least one deadline comprises outputting the notification after determining a task associated with the deadline has not been completed.

23 . A non-transitory computer-readable medium tangibly embodying executable code for managing a clinical trial, the code comprising:

code for receiving input representing that a site visit has been completed and an identifier of a report type for a site visit report;

code for determining, by a computing device, at least one deadline for completing the site visit report for the site visit based on a completion date of the site visit and output a notification to an associate about the at least one deadline;

code for determining, by the computing device, at least one question of a plurality of questions that is associated with the identifier and configure a user interface to include the at least one question; and

code for, in response to receiving an approval of the site visit report, outputting the site visit report.