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In This Issue (click
titles):
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Payroll Dates for HRA
|
Period |
Timesheet |
Payday |
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02/16-02/28 |
03/07 |
03/14 |
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03/01-03/15 |
03/21 |
03/31 |
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03/16-03/31 |
04/07 |
04/15 |
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Tips
for Reimbursements
contributed by Andrea Bains, HRA
Budgeting • If you’re ever unsure that the
backup you send in with reimbursement requests isn’t
enough, please send in as much as you can - more is
better!
• For Independent Contractor invoices: We
need the contractor’s address, signature, and social
security # for our records. We cannot process the
request until this information is provided.
•
Please send in the original receipts, especially when
the purchase is office equipment. HRA is responsible for
the liability on those items.
• Salary or
Independent Contractor invoices for Principal
Investigators must be signed and approved by your
Department Chair.
• Please take advantage of all
available forms. We have different forms for each kind
of reimbursement: Travel, Mileage, Independent
Contractor, Research Subject, and Purchase Requisition
for all other kinds of reimbursements. If you ever run
out of forms, please don’t hesitate to call or send a
quick email.
Memo to P.Is - Closing Old
Accounts
• If you have too many accounts that
have received their final payments, a good option is to
ask us to open up a Various Account. Everything can be
rolled over into that one account!
• If projects
are at zero balance, please send in a quick memo asking
us to close the accounts.
Andrea Bains,
HRA
Budgeting
(323) 223-4091 ext 126
abains@health-research.org |
Position Announcement:
President & CEO,
Health Research
Association
Health Research Association (HRA)
is seeking a President and CEO. HRA is a private
non-profit organization founded in 1947 to conduct and
manage medical, health, and scientific research. More
than 80% of the research conducted by HRA is sponsored
by private industry, with nearly 200 pharmaceutical
company supported studies contracted annually.
The ideal candidate should have over ten years
of senior management experience, preferably in
non-profit and for-profit environments. Experience in a
clinical research environment is preferred. A master’s
degree or equivalent is desired.
A detailed
position profile is available. Inquiries and résumés
should be directed to:
Johnston and
Company
Attn: HRA
6167 Bristol Parkway,
Ste.140
Culver City, CA 90230.
Fax: 310-410-3906
E-mail johnstonco@earthlink.net
Additional
information about Health Research Association can be
found at: www.health-research.org |
Tech Tips:
Windows
Shortcuts
CTL-ESCAPE - Display the
Start menu
SHIFT - TAB - tab backwards through a
form
CTRL - X - Cut
CTRL - C - Copy
CTRL - V -
Paste
F1 - Help menu
CTRL - Z - Undo
SHIFT
& Restart - To restart just windows and not your
whole computer, hold down the shift key when you click
the OK button on the shutdown screen. Saves lots of
time.
File & Desktop
Shortcuts
Hold SHIFT while inserting a CD -
Prevents the CD from "autorunning"
If an item
is selected:
CTRL while dragging a file - Copies
the file
CTRL - SHIFT while dragging a file - Creates
a shortcut to the file
SHIFT - DELETE - Deletes an
item without sending it to the recycle bin.
ALT-ENTER
- Display a file's properties.
F2 - To rename the
file
In Windows
Explorer:
BACKSPACE - View the folder one
level up
ALT- RIGHT ARROW - Move forward to a
previous view
ALT- LEFT ARROW -Move backward to a
previous view
LEFT ARROW - Collapse the current
selection if it is expanded
NUM LOCK-MINUS SIGN (-)
- Collapse the selected folder
RIGHT ARROW - Expand
the current selection if it is collapsed -Or- Select the
first subfolder
F6 - Switch between left and right
panes |
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| March
2003 |
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If you would like to request a paper version of
this newsletter, please send an email to: info@health-research.org.
Please include your mailing address.
You may
now link to the email addresses of HRA Administrative
Employees! Just click on the name of the employee you
wish to email. CLICK HERE for
the list of
names. |
HIPAA Update: IRB Related
Issues
Contributed by the
IRB Upcoming HIPAA Implementation Date April
14, 2003: We are required to comply with new Federal
Regulations regarding the confidentiality of patient health
information (HIPAA privacy regulations). The following IRB
related items need to be completed to satisfy the
regulations:
Need
more
information?
Access
online education
program, template documents,
and
policies and procedures
available on the USC Office
of
Compliance Web site:
www.usc.edu/compliance
Want to arrange
for a presentation
on HIPAA?
Contact the
Office of
Compliance at
(213) 740-8258 or
email complian@usc.edu |
Informed
Consent Issue:
a) Informed Consents (without
HIPAA–compliant provisions) approved prior to April 14, 2003,
must attach a HIPAA authorization addendum to their Informed
Consents for new subjects who will be accrued on or after
April 14, 2003.
• Get the Addendum template from the
Compliance Office website www.usc.edu/compliance or the IRB
website http://ccnt.hsc.usc.edu/irb/irb.html
b) When you submit Informed Consent(s) [either new
submission or revision] to the IRB on or after April 1, 2003,
you need to add the required language (HIPAA-compliant
provisions) in your Informed Consent(s).
• Get the
language from the Informed Consent template on the IRB website
http://ccnt.hsc.usc.edu/irb/irb.html.
• The text is inserted just before the California
Patient Bill of Rights in the Informed Consent
template.
• Submit the revised Informed Consent (one
clean and one marked copy) to the IRB for approval.
You
cannot accrue new patients after 4/14/2003 if you do not have
either the HIPAA Authorization Addendum, or IRB approved
revised Informed Consents that include the HIPAA provisions.
Click here for
continuation of HIPAA information
below....
Spotlight on Project Employees: Jose
Goico
"Making a Difference"
Contributed by Kimberley Mooney of HRA’s Human
Resources department Congratulations to Jose
Goico, our Project Employee of the Month!
For those of
you who don’t know Jose Goico’s name, you would probably
recognize him as the man who, while he hurries past you in a
flurry of activity, slows down to flash a smile at you.  In June, Jose will celebrate nine years with HRA
as a Clinical Research Associate for Dr. Thomas Buchanan. In
1985 Jose received a Doctorate of Medicine in the Dominican
Republic and has been in the healthcare industry for over 20
years. His passion for helping people has always led him to
work closely with patients, an area in which he
excels.
The most exciting and fulfilling event of
Jose’s career thus far was helping to complete a
five-and-a-half-year Tripod study with LAC + USC’s Diabetes
Research Study Phase III & IV. The sense of achievement he
experienced strongly reinforced his devotion to the work. Dr.
Buchanan recognizes this; “Jose is the driving force behind
the diabetes prevention studies. He is extremely dedicated to
his work, very knowledgeable, and wonderful with our
patients.” Click here
for continuation of Jose Goico feature
below....
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Grants & Contracts Update:
Setting Up a
Successful Project Closing
Contributed by Kathi Biem of HRA's Grants &
Contracts Department As studies near their end
date, there are some ways to have a successful close out
phase. These steps are just as important as those at the onset
of contract negotiations.
To maintain efficiency in
the close out phase of a study project, the first thing
required is an accurate enrollment list to include on/off
study dates and completed cycle data, if applicable, as soon
as practical. This allows HRA sufficient time to calculate and
collect any payments still due from the sponsor. Most
contracts have a definite time period to submit this
information to them, as well as to make adjustments in the
final payment. We are also obligated to return any unused or
unearned monies to them, unless the PI can provide a written
justification of expenses for the sponsor’s
approval.
As all payments are collected, you can submit
requisitions for your final expenses. We can only close out
the study when projects are at a zero balance. However, the
last remaining requirement is to have the PI submit a
written authorization for closure. Once projects are
closed, they no longer generate PSR’s (project status
reports), and this will cut down on the amount of mail you
receive!
As always, please contact Kathi Biem or Denise
Deack at (323) 223-4091 with your Grants & Contracts
questions.
Kathi Biem: kbiem@health-research.org
Denise Deack: ddeack@health-research.org
Patient Relations
Excerpted from Clinical Trials Advisor
Newsletter Beyond securing informed consent,
patient enrollment needs to result in the participant’s
complete buy-in and understanding of the trial. The
relationship between the patient and physician and
coordinator, and especially first impressions, can be the most
important aspects of patient retention.
Educating
patients and building relationships are vital steps not only
initially, but throughout the study as well, experts agree.
Clinical Trials Advisor interviewed several industry
professionals about how to make a good first impression and
keep patients on board. Here’s what they
recommend:
Be a Resource for Patients. “I always
try to make sure that I understand the protocol so I can give
them real answers,” says one industry professional. “I also
make sure I understand the procedures they are facing, and
hope that I can help put their mind at ease. I try to be as
thorough as possible in explaining the study for
them.”
Give patients the rationale for what you’re
asking them to do. For example, in studies involving
diabetic patients, there’s often a lot of dietary management.
Tell patients why diet is important. It’s not always enough to
simply tell a patient they have to do something. You can
improve compliance if you tell them why.
Demonstrate
a commitment to patient safety and well-being. Be a
patient advocate. Let patients know that they are going to be
closely monitored and cared for. Tell patients that you will
monitor their health status and how. Stress that you will not
let them be at risk.
Use examples and specifics when
possible. For example, if the informed consent lists 50
side effects, the physician could discuss the four or five
that are most likely to be experienced.
Be
straightforward. You want to be sure patients are fully
aware of their responsibilities and then ask for their
commitment. Be sure to tell them of any study requirements
they may have to do at home, such as maintaining diaries or
self-administering medications. And make sure they have plenty
of opportunities to voice concerns or express
difficulties.
Focus your attention on them. Give
patients the uninterrupted time they deserve. For example,
don’t jump up and answer your pager. Sit down with them and
don’t rush the process. It’s important not to rush the patient
or the process. It’s better to advise them to hold off signing
the consent form too early on, and make sure all their
questions are answered first.
Maximize the
physician-patient relationship. Encourage patients to ask
questions of the physician. One physician investigator takes
new patients into his office to provide a more comfortable
setting for discussion, because she believes it’s much more
comfortable for the patient than being in a paper gown in a
treatment room, and may add to the compliance
rate.
Another investigator finds that many times
patients will talk at greater length to a physician. “Even
when coordinators offer patients the opportunity to talk and
ask questions, some people just prefer to talk with the
physician.”
Communicate, communicate,
communicate. Reminder calls before a visit and thank-you
postcards afterwards can mean a lot to study patients. Also,
tell them what to expect at each visit and review results of
any tests. Offer them copies of test results. Write reminders
on their appointment cards, such as medication dosage
instructions.
Emphasize that the patient has the
“ultimate out.” Even after patients consent to participate
in a study, they can still back out. But many don’t want to
“disappoint” or appear to be disagreeable. Let them know it is
okay to change their minds. “I tell patients up-front that
they can choose not to go forward with the study,” says an
investigator. “I tell them that I know they have a lot on
their plates to deal with, facing a dramatic surgical
procedure, and that they can back out right then and
there.”
Show empathy and compassion. A few words
of understanding can go a long way. Acknowledge that they are
already in a stressful situation and their anxiety level must
be high - they appreciate that. A simple nod or touch on the
arm can sometimes say more than words; a gentle reassuring
voice can make the difference.
Express appreciation
at every opportunity. Use every interaction with the
patient to reinforce how much you appreciate their
participation. Reinforce their contribution and their
commitment.
Be sure to include family members.
It’s a good idea to make eye contact with all family members,
as they need to be assured that their questions and concerns
are just as important as the patient’s.
| Clinical Trial Opportunities from
HRA |
Below is a
list of those studies received by HRA in February 2003. Please
contact HRA immediately if you are interested in any of these
opportunities.
We also have the ability to conduct a
personal study search for LAC+USC investigators. Contact us at
info@health-research.org for
further information on a specialty-targeted study (there is no
cost associated with this).
Phase I
BioCell Technology
LLC
Drug Name: BioCell Collagen II
(dietary
ingredient)
Specialty:
Dermatology,
Musculoskeletal
Indication:
Skin health
HRA Reference number:
08-03-03
Phase IV
CareStat
Drug Name: Not
available
Specialty:
Nephrology
Indication: Anemia with
Chronic Kidney Disease
HRA Reference number:
09-03-03 |
Phase III
Quintiles
Drug name: not
available
Specialty:
Oncology
Indication: Advanced
unresectable
adenocarcinoma of the
pancreas
Notes: study of new anti-cancer
agent
plus gemcitabine versus gemcitabine alone
HRA
Reference number: 06-02-03
Phase III
Merck and Co.,
Inc.
Drug Name: Not available
Specialty: Pediatrician with
vaccine
trial experience
Indication: Pediatric
vaccine
HRA Reference number: 07-03-03
CenterWatch: Seeking Investigators
Phase I
Pro-Pharmaceuticals
Maureen
Foley
Email: foley@pro-pharmaceuticals.com
Drug
name: Not available
Specialty:
Physician working with HIV and/or studying HIV, including
virologists
Indication: HIV/AIDS
Notes:
Active ingredients delivered by suppository. There are several
purified herbal constituents as well as a non-toxic chelating
agent.
Phase II
Arkos BioDevelopment
International
Naomi Muha
Email: nmuha@arkios.com
Drug name:
Gallium Nitrate
Specialty:
Medical Oncology
Indication: Non-Hodgkin's
Lymphoma
Medennium, Inc.
Natasha Behrmann
Email:
nbehrmann@medennium.com
Device
name: Matrix Acrylic IOL
Specialty: Cataract
Surgeons
Indication:
Cataracts
(HIPAA
continued)
HIPAA Education
Issue:
a) The PI/Co-PI(s) are responsible for
ensuring that all study personnel have completed the HIPAA
education certification program. All personnel who use
identifiable health information (individual’s past, present or
future physical or mental health condition or payment for
health care) in conducting research must take the HIPAA
education program. Examples of research personnel include PI,
Co-PIs, Co-Investigators, and individuals authorized to obtain
Informed Consent and/or involved in data collection by using
identifiable health information of the research subjects. The
PIs’ HIPAA education certificates should be submitted with
each New Proposal IRB Application form and with each
continuing review form. USC’s Web-based HIPAA education
program is now available for certification.
• Go to the
USC Office of Compliance website www.usc.edu/compliance. Take the
education course and test. You can print out a certificate
upon completing the program.
• Any questions/problems
regarding this web education, call the Compliance Office at
213-740-8258.
b) IRB application Section I is now
revised to add a check box for “Identifiable Health
Information” under the Nature of Research section. You must
mark this box if you need to access or use patient/subject
identifiable health information (e.g. medical records, mental
health information, lab reports, x-rays, tissue samples) for
your research. If this box is checked, the PI must submit
HIPAA education certificates for the PI and Co-PIs to the IRB.
Page 2 of Section I is also revised to add a statement to the
“PRINCIPAL INVESTIGATOR’S ASSURANCE AND SIGNATURES”: “I
certify that all study personnel have completed the HIPAA
education program and are certified.” The statement clarifies
the PI’s responsibility.
• Get the revised Section I
from the forms section of the IRB website: http://ccnt.hsc.usc.edu/irb/irb.html
After 4/14/2003, the IRB will not review your new
study until the IRB receives verification of the PI/Co-PIs’
completion of the USC HIPAA educational program. As for
continuing reviews, the IRB will not grant its full approval
until the IRB receives verification of completion of the HIPAA
education program from the researchers.
There are some
exceptions - not all human subject research needs HIPAA
authorization. For example: a) de-identified information; b)
limited data set certified by the researcher; c) IRB waiver by
meeting waiver criteria; d) preparatory to research certified
by the researcher; and e) decedents research certified by the
researcher. Please visit the Compliance office website or call
the office for further information and clarification of these
exceptions.
Jose Goico
continued
Dr. Buchanan has served as Jose’s
instructor and mentor. He trained Jose in all clinical aspects
of the study including performing oral glucose tolerance
tests, IVGTT’s and setting guidelines for the recruitment of
volunteers. Jose has always enjoyed the technical aspects of
his job but takes the most pleasure in helping his patients.
In a large sense, Jose has become a counselor, someone who
listens and empowers his patients to care for themselves and
their families. He educates people to control the disease by
improving their diet, lifestyle, and mental outlook. He’s
helped win small and large victories with his patients and has
had remarkable success in recruiting almost all of the
participants from his first study for his current project.
Interestingly, Jose is an avid and extremely
accomplished reader. His favorite authors range from Alexander
Dumas and Moliere to Dostoievsky, Tolstoy, and Nabakov. Yes,
he’s read War and Peace!
He is continuously trying to
improve his life professionally and spiritually. By the end of
2003, Jose plans to earn an Associate of Research
certification.
Jose Goico offers the best gift of all
to patients, the power to help themselves. And, in this way,
truly makes a difference.
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