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In This Issue (click
titles):
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Period |
Timesheet |
Payday |
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12/16-12/31 |
01/08 |
01/15 |
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01/01-01/15 |
01/23 |
01/31 |
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01/16-01/31 |
02/07 |
02/14 |
HRA has designated the following
holidays for 2003:
Wednesday, January
1 -
New Year's
Day
Monday, January 20 -
Martin Luther King Jr.
Day
Monday, February 17 -
Presidents' Day
Monday,
May 26 -
Memorial
Day
Friday, July 4 -
Independence Day
Monday,
September 1 -
Labor
Day
Monday, October 13 -
Columbus Day
Tuesday,
November 11 -
Veterans'
Day
Thursday, November 27 -
Thanksgiving Day
Friday,
November 28 -
Day after
Thanksgiving
Thursday, December 25 -
Christmas
Day |
Industry Brief: Regulatory
Changes
The Office for Human Research
Protection has outlined its goals for 2003 following the
resignation of its director Greg Koski. New goals
include building on a number of Koski incentives. The
agency’s main goals include increased collaboration
through public-private partnerships, an emphasis on
simplification, more educational seminars and additional
accountability in the areas of quality improvement and
compliance oversight. |
Tech Tips - Microsoft
Word
If you need to distribute a
document for edits and comments and you want Word to
track the changes, use the Send for Review feature. To
do this, click File | Send To | Mail Recipient (for
Review). When your reviewers use the Reply with Changes
option, the file comes back to you, and Word prompts you
to merge the documents, at which point you see all of
the changes that your reviewers have made.
You
can force Word to record revisions made by anyone
who edits your file. Simply click Tools | Protect
Document, select Tracked Changes, and enter a
password.
Word's custom dictionaries are
plain text files, so you can easily add lists of words
in a single operation using Windows' Notepad. Use
Windows' Search (or Find, depending on your operating
system) to locate the Custom.dic file. The exact
location of the file differs according to your version
of Windows. |
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| January
2003 |
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HRA's 2002 Holiday Open House A
Success!
In an effort to open our doors and
lines of communication to HRA’s valuable project employees, we
hosted an open house this month. Because of the overwhelming
response we received, we plan to make this an HRA
tradition!
More than 90 people joined us for a tour of
our office and an opportunity to learn a little about our
goals for 2003. Each department is focused intently on
increasing communication, improving accuracy, developing
quality programs, and ultimately discovering new ways to
perfect how we can support you.
Our partygoers enjoyed
hors d’oeuvres, holiday music, a presentation of our newly
launched website, www.health-research.org, and of
course, meeting new and familiar friends.
If you heard
that just by showing up, grabbing a snack, and talking to
friends meant that you were entered in a raffle, you heard
right!
THE LUCKY WINNERS OF GIFT CERTIFICATES TO
ROBINSON’S MAY AND BEST BUY ARE AS
FOLLOWS:
Diane Citron, Jose Goico, Rosalinda
Munoz, Paul O’Neil, Martha Patel, Lila Rodriguez, and
Brandon Schmidt
We at HRA would like to thank
each and every person who attended, and also express our deep
appreciation for the hard work you do to uphold your superior
standards. We are proud to work with you!
New shipment of FREE Research Coordinator
Booklets has arrived- Request yours
today!
HRA has just
received a new shipment of pocket-sized manuals for
Research Coordinators. The booklets are a handy
reference tool for anyone involved in the research
process. If you have not yet received your copy, call Jo
Anne Mastrangelo or Laura Recchi at HRA (323) 223-4091,
or send an email to: info@health-research.org |
Grants &
Contracts
At HRA’s recent open house, the
Grants & Contracts (G&C) office listed our commitment
to improving customer service as our top goal for the coming
year. The most important avenue through which this can occur
is via open communication between HRA and the research teams.
In effect, the successful attainment of OUR goal
depends to a large extent on YOU! While HRA must
provide you with periodic status reports on the process for
each study, we also need communication from the study teams on
important project information to continue the unimpeded flow
(which includes expenditures) within the studies. Following is
a list of changes in the study that we need a designated
research team member to communicate to HRA:
Information HRA Needs to
Keep Your Study on Track
PI
Changes—HRA needs to be notified immediately when the PI
on a study changes. Why? 1) HRA has an obligation to notify
sponsors and CROs, 2) a change in the PI requires an amendment
to the original agreement for legal and audit purposes, 3) we
need to notify sponsors and CROs to change the payment
information (to enable us to credit the proper project with
deposits), and finally, 4) for audit purposes, we need to have
the correct IRB approval letter filed in each study
folder.
Enrollment—HRA needs periodic updates on
each patient enrolled, as some sponsors request invoices
before they will process payments. Generally, all we require
is some type of patient identification such as a number or
patient initials, plus the dates of enrollment and off study.
In the case of studies with various cycles of treatment, we
also need the specific cycle for each subject. This
information is used for audit purposes as well, to determine
the correct amount of payments upon study
closure.
Study Changes—If the study 1) closes,
2) is put on hold for protocol changes, or 3) the sponsor
terminates it early for any reason, HRA needs to be notified.
If the study is on hold for an extended period of time for
protocol changes, waiting for FDA approval, etc., this may
require contractual changes. If the study is completed or
terminated early, we need to begin the audit process to
determine the correct amount of payments still due, or that
may need to be returned to the sponsor or CRO (we generally
have a time limit on this).
For any of the above
changes, please contact:
Kathi Biem
Email: kbiem@health-research.org or
phone (323) 223-4091
or
Denise Deack
Email: ddeack@health-research.org or
phone (323) 223-4091
Clinical
Research Training and Certification
For the
past few years, the Association of Clinical Research
Professionals (ACRP) has been monitoring the training and
certification needs of clinical investigators. The latest data
indicate that more work needs to be done in this area
worldwide. It has been reported that 50% of clinical
investigators who do one trial never return to do a second
one. This information suggests that investigators are not
being given enough tools to succeed. Investigators may have
varying skills and training, which could produce varying
levels of success for clinical trials.
ACRP developed
its Good Clinical Practices (GCP) for Investigators course as
a pilot program to address the need for further
standardization or minimum preparation requirements. The
results of the pilot course were so encouraging that the
association committed to a full rollout. The GCP course now
goes hand-in-hand with ACRP’s Certified Clinical Research
Investigator (CCRI) program, which welcomed its first class of
certified investigators this year.
There are now
several pharmaceutical companies that offer their own version
of GCP training courses to investigators, and the likelihood
of additional sponsors requiring further training or
certification is growing. By pursuing training and
certification, investigators are voluntarily raising the bar
for standards in their profession, proactively making a
commitment to safe and efficient studies.
ACRP
Seminars
If you are interested in advancing
your career as a CRC or CRA, or would like to expand your
understanding of the basic elements of clinical research,
ACRP's Seminars in Clinical Research are for you. Offered
throughout the year, each seminar provides intensive,
interactive training that is applicable to your clinical
trials. Topics cover the Fundamentals of Clinical Trials,
Intermediate CRC Training, Intermediate CRA Training, and
exciting new seminars that focus on hot industry topics such
as Applied Ethics, FDA Inspection Readiness, Clinical Trial
Budgeting, and more.
The Good Clinical Practices (GCP)
for Clinical Investigators programs offer intensive training
to clinical investigators and their study staff. This
three-day GCP training program will provide you with the
training needed to improve your trials and ensure compliance
with good clinical practices, FDA regulations, and ICH
guidelines. Using interactive exercises, lectures and
informative question and answer forums, the GCP training
programs give investigators, study coordinators, institutional
review board members and other members of the study team the
right tools to conduct cleaner, safer, more efficient clinical
trials.
Click here for ACRP Schedule of
Events
For more general information
about ACRP visit their website at acrpnet.org
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IRB Update
Informed Consents and California
Law
There have been some changes made to
the regulation (California Law, Section 24178) regarding who
can sign the Informed Consent in cases where a research
subject is unable to give consent. A new Assembly Bill 2328,
which expands the definition of those individuals who can
provide informed consent in medical research, will become
effective on January 1, 2003.
"This bill would
authorize certain persons to give surrogate informed consent
for a person to be subjected to a medical experiment when
conducted within an institution that holds an assurance with
the DHHS....if that person is unable to give that consent.
This bill will provide that these provisions apply only to
medical experiments that relate to the cognitive impairment,
lack of capacity, or serious or life threatening diseases and
conditions of research participants."
---Legislative
Counsel's Digest
Please review the bill at:
http://www.leginfo.ca.gov/pub/01-02/bill/asm/ab_2301-2350/ab_2328_bill_20020912_chaptered.html
Research Coordinator Meeting: HIPAA
Simplified
At the last meeting, an excellent
overview of the HIPAA (Health Insurance Portability
Accountability Act) was presented by Ms. Jody Girten from the
USC Compliance Office. We will have another meeting covering
the interpretation and more practical applications of this
Act. The speaker will be Dr. Darcy Spicer, the Chair of HSC
IRB. The following date and time have been set:
Date:
3/05/2003 (Wednesday)
Time: 12:00 noon - 1:00 pm
Place:
TBA
I will let you know as soon as the location is
decided. In the meantime, for any questions, call or e-mail
me.
Fumi Stark, MA
Education and Audit
Director
HSC Institutional Review Board
tel: (323)
276-2226
e-mail: stark@usc.edu
Save Time and Money with HRA's Purchasing
Department
Did you know that using Health
Research Association’s purchasing services SAVES
investigators' time and money? Veteran investigators know how
time-consuming it is to order office supplies, laboratory
equipment, chemicals, computers, and office furniture. There’s
also package tracking, order verification, defective returns,
wrong sizes, and expired products; the list goes on and on.
Let’s face it, time is money. Rather than spending scarce time
handling these issues, why not let HRA’s purchasing department
handle it for you? We offer a first-class purchasing team of
expert negotiators, quick thinkers, and natural problem
solvers.
To save you money, we compare prices with
preferred vendors. Additional savings come from preferred
accounts with manufacturers and distributors such as: Dell
Computer, Allegiance Health Care, Fisher Scientific, Office
Depot and many others.
HRA’s purchasing department is
a great resource for both new and established investigators.
So why not let HRA’s purchasing department free up some of
your valuable time? Use HRA to do the work for you.
For more information regarding our value added
services, please call Purchasing Department at (323)
223-4091.
CenterWatch:
Seeking Investigators
Phase I
TAP
Pharmaceutical Products Inc
Matt Mockler, CRA
Email: matthew.mockler@tap.com
Drug name:
Not available
Specialty: Phase
I Experience
Indication:
Endometriosis
Phase II
Cytokine
Pharmasciences, Inc.
Email: aupadhyay
@cytopharmasciences.com
Drug
name: CNI-1493
Specialty:
Gastroenterology, Internal Medicine, Family Practice, General
Surgery
Indication: Crohn’s disease (moderate to
severe)
TAP Pharmaceutical Products Inc.
Matt
Mockler, CRA
Email: matthew.mockler@tap.com
Drug name:
Not available
Specialty:
Rheumatology, Internal Medicine
Indication:
Gout
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