Systems and methods for source document management in clinical trials

1 . A method comprising:

receiving a clinical trial form on a client device over a network from a server device, the clinical trial form comprising a plurality of form data fields;

receiving structured clinical trial data associated with at least one of the plurality of form data fields;

receiving unstructured clinical trial data; and

transmitting the structured clinical trial data and unstructured clinical trial data to the server over the network.

2 . The method of claim 1 , wherein the unstructured clinical trial data comprises digital ink.

3 . The method of claim 1 , wherein the unstructured clinical trial data comprises at least one of a signature or an annotation.

4 . The method of claim 1 , wherein the client device comprises a tablet PC.

5 . The method of claim 1 , wherein receiving structured clinical trial data further comprises converting the unstructured clinical trial data to structured clinical trial data.

6 . The method of claim 1 , further comprising:

receiving a request to check out previously entered structured and unstructured data associated with a patient; and

causing the previously entered structured and unstructured clinical trial data to be displayed with the clinical trial form.

7 . The method of claim 1 , further comprising validating the structured clinical trial data before transmitting it to the server.

8 . The method of claim 1 , further comprising validating the structured clinical trial data before transmitting it to the server.

9 . The method of claim 1 , further comprising:

disconnecting from the network after receiving the clinical trial form; and

reconnecting to the network before transmitting the structured clinical trial data and unstructured clinical trial data to the server.

10 . A computer-readable medium on which is encoded processor-executable program code, the computer-readable medium comprising:

program code for receiving a clinical trial form on a client device over a network from a server device, the clinical trial form comprising a plurality of form data fields;

program code for receiving structured clinical trial data associated with at least one of the plurality of form data fields;

program code for receiving unstructured clinical trial data; and

program code for transmitting the structured clinical trial data and unstructured clinical trial data to the server over the network.

11 . The computer-readable medium of claim 10 , further comprising:

program code for receiving a request to check out previously entered structured and unstructured data associated with a patient; and

program code for causing the previously entered structured and unstructured clinical trial data to be displayed with the clinical trial form.

12 . The computer-readable medium of claim 10 , further comprising program code for generating the clinical data form, the structured clinical trial data, and the unstructured clinical trial data in a human-readable.

13 . A system comprising:

a client device in communication with a server device over a network;

a clinical trial data capture architecture on the client device, the clinical trial data capture architecture configured to:

receive a clinical trial form on a client device over a network from a server device, the clinical trial form comprising a plurality of form data fields;

receive structured clinical trial data associated with at least one of the plurality of form data fields;

receive unstructured clinical trial data; and

transmit the structured clinical trial data and unstructured clinical trial data to the server over the network.

14 . A method comprising:

transmitting a clinical trial form to a client device over a network from a server device, the clinical trial form comprising a plurality of form data fields and a plurality of validation rules;

receiving structured clinical trial data associated with at least one of the plurality of form data fields from the client device;

receiving unstructured clinical trial data associated with the clinical trial form from the client device; and

outputting the structured clinical trial data and unstructured clinical trial data.

15 . The method of claim 14 , further comprising generating a human-readable document containing the structured and unstructured data.

16 . The method of claim 14 , wherein the unstructured clinical trial data comprises digital ink.

17 . The method of claim 14 , wherein the unstructured clinical trial data comprises at least one of a signature or an annotation.

18 . The method of claim 14 , wherein the client device comprises a tablet PC.

19 . The method of claim 14 , further comprising generating the clinical data form, the structured clinical trial data, and the unstructured clinical trial data in a human-readable form.

20 . The method of claim 19 , wherein the human readable form comprises a portable document format (pdf) document.