07/22/2006
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CREDIT:
1. There is a new web "Updates" site for all DDOTS, Inc. software systems: http://64.109.156.30/ddotshelp/Index.cfm
This site has Frequently Asked Questions about CREDIT, IDEA, and IRBANA. Newly added to the site is the email listing of System Updates...(copies of these emails). That is under the page link: DDOTS, Inc. System Update History. Once inside of the Update page, users can search for specific text to find an update for review. Clicking on the Date of the Update selects that single update for review\printing.
2. For those institutions that have the System Variable Enabled to "Show Staff Notations in Patient Checkoff Calendars", there is a new Column box in the Master Schedule Report: Patient Calendar Notes. If checked, the notes show, if unchecked (default) the notes do not show.
3. When adding a study Review History entry, CREDIT takes the current status of the protocol for the institution and defaults that entry as the status as of the time of review. Now, when editing an entry, staff can change the status of an historical entry. Caution: The actual protocol status is located on the Protocol Data Page. The status in the Review History page is intended to be a "capture" of the status as of that specific IRB Meeting. The status in the Review History should ONLY be changed if it was entered in error.
4. For CCOPs, the Sex and Ethnic Participation Table 4 now paginates with subsequent pages containing the header information.
5. The Continuing Review Report now has links on the LAST REVIEW DATE to popup the complete review history for the study.
6. The Master Schedule Report now has 4 Key Word entry boxes for locating specific Patient Calendar Activities. Previously, there was only one Filter Word box.
7. There is now a "Current Consent Date" available on the Protocol Data Page. To enable this feature, File Operations > System > System Variable Default Values > # 62 must be ENABLED. By default, it is DISABLED.
8. There is now a "Termination Date" available on the Protocol Data Page. To enable this feature, File Operations > System > System Variable Default Values > # 63 must be ENABLED. By default, it is DISABLED.
9. There is a new "Secondary" Consent Date that is available for patients that are accrued to the same protocol and arm. This can happen when a study has a single arm, and the arm is simply a tissue sample. A patient may provide the sample for each surgery that would require a new consent date for each submission. If the patient is only accrued to the protocol once, the Secondary Consent Date does not display.
10. The long anticipated IRB Regulatory Deviation Log is finished. It is located in the protocol Mini-Menu with all the other Regulatory pages. The Deviation can simply be added or the Add & Print button allows for immediate printed output. Prior to use:
You will need to go into File Ops > IRB > Add Regulatory Deviation Type
Sample:
Emergency:
Eligibility
Study Drug Dosing
Use of Device
Preparative Regiment
NonEmergency:
Laboratory Requirements
Procedure Requirements
Follow-up Requirements
Other (Explain Below)
Then, go in and add Questions: File Ops > IRB > Add Regulatory Deviation Question
Sample:
Did the deviation affect the rights, safety, or welfare of the subject? (if YES, explain)
Was the deviation instituted to protect the subject from immediate hazard?
Did the deviation affect the integrity of the study data?
Has this deviation occurred in the past? (if YES, explain)
Has this event been reported to the Sponsor? (if NO, explain)
11. There is a new Report Form in the IRB column: Deviation Report Form. A sample form has been added to each IRB. This form can be edited in the stated report. The macros available for the report are in the form.
IDEA:
See CREDIT items: 1, 2, 3, 5, 7, 8, 9, 10, 11
IRBANA:
1. See CREDIT items: 1, 5, 7, 8, 10, 11 |