New Required Data Elements for ClinicalTrials.gov
Public Law 110-85 took effect in September 2008, which
expanded the types of clinical trials that must be registered with
ClinicalTrials.gov.
New requirements increase the number of data elements that
must be submitted to ClinicalTrials.gov for each initial trial registration.
Effective December 1, 2012 the following data elements will be required to post
a new study record:
- Responsible Party;
- Primary
Completion Date; and
- At
least one Primary Outcome Measure.
If you have general questions, please contact the UW
Compliance Administrator, Stefan Shipman, at sshipman@uw.edu.
REMINDER & NEW TIMELINE - Medical Records Review Form Substantially Revised!
If you will
be conducting research that only involves identifiable biological specimens
and/or data, a substantially revised form with new guidance has been created
titled: Use of Identifiable Specimens/Data. These replace the old
"Medical Records Review" form and instructions.
The form is limited to researchers who
are not directly interacting with people, but who are reviewing identifiable
private information about individuals and/or analyzing identifiable specimens.
When should you complete this
application? Here are some examples of projects that involve review of
identifiable information or specimens (either retrospective or prospective)
that are appropriate for this form:
- medical records;
- protected health information (PHI);
- employment data;
- study records;
- pathology specimens;
- data and/or specimens from a repository.
The
deployment of a revised Use of
Identifiable Specimens/Data form and guidance will involve a beta-testing
phase:
Step 1 - Friday, 8/10/2012 - a PDF version of the Use of Identifiable Specimens/Data was made available for beta-testing, along with the guidance document.
Step 2
– Friday, 8/10/12 through Thursday, 11/15/12 – Please direct comments/questions
about the form to hsdinfo@uw.edu
Step 3 - Friday, 11/30/2012 (target date) – All received
comments will be incorporated. A
finalized PDF form and guidance will be made available.
The form is
available on the HSD website:
http://www.washington.edu/research/hsd/docs/1377
and should be
used in direct conjunction with the guidance:
http://www.washington.edu/research/hsd/docs/1357
As of December 31, 2012 (deadline extended), HSD will no longer accept the old "Medical Records Review"
form.
Please direct
any questions about the form to hsdforms@uw.edu.
**NEW - the form will also be available in Word.**
New Metrics Available
The 16th Report of HSD Performance Metrics (for reporting period 4/1/12 to 9/30/12) has been posted to the HSD website.
This report includes a new metric and analysis of "Minimal Risk" reviews. Turn-around times are now distinguished by type of application form.
- The standard application has a median turn-around time of 23 business days.
- The medical records review form (soon to be replaced by the Use of Identifiable Data/Specimens form) has a median turn-around time of 14 business days.
This information should prove to be very helpful to those researchers in the School of Medicine who do outcomes research using medical records.
Information about turn-around times and other key aspects of the IRB review process can be found in the report at http://www.washington.edu/research/hsd/docs/1476 along with reports from previous quarters.
2013 Update to the International Compilation of Human Research Standards
The International Compilation of Human Research Standards is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in 104 countries and from several international organizations. The Compilation is designed for use by IRBs, researchers, sponsors, and others. Many of the listings embed hyperlinks to the source document.
The 2013 edition is now available, and can be accessed in both Word and PDF formats: http://www.hhs.gov/ohrp/international/index.html. One new country is featured in the 2013 Edition: Ecuador.
As in the past, the new edition updates the human research standards based on information provided by in-country experts.
New and Revised Documents
You may have noticed that HSD has been releasing new or revised policy, procedure, and guidance documents at a brisk pace. This is a major effort that will continue during the coming year, due to:
- Campus requests
- HSD's goal of increasing transparency and knowledge about the IRB review process
- The increased frequency of federal regulatory changes
We generally release and post all new and revised documents on the last Friday of every month. We use this newsletter to alert you to those new documents. We hope you like our format for presenting the information, and we welcome feedback and suggestions. (hsdforms@uw.edu)
| Topic |
Adverse Event Reporting |
| Document(s) |
REMODELED Adverse Event Report Form
|
| Description |
Remodeled to PDF. No content was changed. |
| Expected impact |
Low
|
| Related changes |
None
|
| Link for more information |
http://www.washington.edu/research/hsd/docs/755 |
| Implementation date |
November 30, 2012 |
| Topic |
Limited Activities Determination |
| Document(s) |
UPDATED Limited Activities Determination Form and Guidance
|
| Description |
Slight changes were implemented in both the form and the guidance to make it more clear that the LAD form is a multipurpose form to be used for initiating, renewing and closing a Limited Activities Determination. |
| Expected impact |
Low
|
| Related changes |
None
|
| Link for more information |
Form:
http://www.washington.edu/research/hsd/docs/1307
Guidance:
http://www.washington.edu/research/hsd/docs/776
|
| Implementation date |
November 30, 2012 |
| Topic |
Exempt Status Request |
| Document(s) |
UPDATED Initial Application: Exempt Status Request
|
| Description |
Instructional text has been added to the PDF version regarding the use of Category 4: Existing Data in Part 3: Exempt Category Selection. No such instruction exists on the Word version, it was updated to have the version and dates match to avoid confusion. |
| Expected impact |
Low
|
| Related changes |
None
|
| Link for more information |
PDF:
http://www.washington.edu/research/hsd/docs/1254
Word:
http://www.washington.edu/research/hsd/docs/1207
|
| Implementation date |
November 30, 2012 |
| Topic |
Status Report Information for Researchers |
| Document(s) |
DELETED Status Report Information for Researchers (J-384)
|
| Description |
This information sheet has not been updated in several years, and is no longer useful. It has been deleted from the HSD website. |
| Expected impact |
Low
|
| Related changes |
None
|
| Link for more information |
None |
| Implementation date |
November 30, 2012 |
 Quick Tips from HSD
How to use the new form: Use of Identifiable Biological Specimens/Data
HSD has officially released the new form and guidance the Use of Identifiable Biological Specimens/Data. The form and guidance pertain to using identifiable data and/or specimens for research. This application replaces the Medical Records Review form.
Last eNews we talked about when to use the new form - this time, let's look at how to use the PDF smart form.
The PDF is intended to guide you through the questions, hiding the questions that you don't need to answer, and revealing follow-up questions that you do. This will save everyone time in skipping over empty boxes, and maybe save a few trees along the way.
Quick Tips is well aware that in some cases, the form is used as a communication tool between research coordinators and researchers to fine tune their application, and make sure all questions are answered appropriately. Word may have an advantage in "Track Changes," but PDF can accept comments. The comment tools will take you back to the days when you turned in a paper and got it back full of red pen and sticky notes! (Or maybe that was just me...)
Here's how you do it:
- Flatten the document by selecting "Print" and changing the printer to Adobe PDF. You will want to save this flattened version with a different name if you are not done with the original form, as flattening is just like printing it to a piece of paper. The fields will no longer be editable.
- You will now be able to make all kinds of comments on the form using the commenting tools.
- If you have the full version of Adobe Acrobat, you could even experiment with shared reviews, collaborating live, and track reviews.
See the Adobe website for more information: http://www.adobe.com/products/acrobat.html
Before you say "Hey, is this just some Adobe endorsement?", know that Quick Tips finds some things about PDF frustrating as well. That's why we'll also be putting out a Word version of the Use of Identifiable Biological Specimens/Data form.
So check it out, and send Quick Tips an email if you find new and exciting ways to collaborate with PDF. We'd love to share them with the research community.
Note: If you forward this newsletter to another email recipient, please
delete the Manage Your Subscriptions or Unsubscribe link, below.
|
