The Clinical Trials Office is the main service organization
for assistance in contract negotiations and protocol development,
providing necessary guidance and administrative resources through
several departmental centers.
Protocol Development & Support
• Contract Analysts
Strategic Planning and
• Budget Analysts
Protocol Development & Support Team
Our Protocol Development & Support Team fosters strong,
progressive protocol development from inception to trial by uniting
many years of knowledge and experience in private industry, and
academic and medical settings. The team works to ensure trial
success and integrity by collaborating directly with investigators
on the improvement and refinement of submitted proposals.
The Contracts Group is the first step towards processing
an industry-sponsored clinical trial. During the first phase
of contract execution, investigators contact this team about
potential proposals. Once notified, teams of project officers
act as the central liaison between investigators, sponsors,
Once a proposal has been submitted to the department, project
officers negotiate the contract and the budget with the sponsor,
as well as assemble all of the necessary documents required
to prepare a file and process a project. When the contract
is negotiated and all regulatory requirements have been met,
the agreement is routed for execution. Upon execution, the
agreement and all pertinent documents are forwarded to the
Strategic Planning and Finance Group.
SOP for Confidentiality Disclosure Agreement (CDA)
Subject Injury Reimbursement Provisions
PI contract review form
Strategic Planning and Finance
The Strategic Planning and Finance Group functions as
the center for clinical trial financial management. Strategic
planning and finance offers assistance in the creation of budgets,
account setup, document tracking, and reimbursement and revenue
analysis. These services are fundamental to creating cost effective
and sustainable research business models. By maintaining accurate
and adequate service records, these invaluable resources are
key to promoting efficient and compliant clinical research.
Additionally, this Group specializes in assessing the
financial risk of clinical trials. Through the establishment
of strategic financial goals, economic benchmarks are tested,
policies are reviewed and modified, and funding opportunities
The Budgets Group provides the first step towards securing a fiscally
Its budget review promotes effective financial management.
Team acts as a liaison between investigators/coordinators and sponsors.
CTO Budget Project Officers work closely with investigators and coordinators to
identify all expenses incurred by clinical trial activity.
Using these projections,
they can then negotiate the optimum dollar amount allowed by the sponsor.
To assist you in planning your proposal budget, you may download the
Spanish Translation Center
The Spanish Translation Center (STC) was established
in 1996 with the goals of enlarging the pool of potential study
participants and reaching out to the Hispanic community, traditionally
under-represented in research studies. Our services are designed
to remove language and cultural barriers to participation in
clinical trials and to afford patients a wider range of treatment
We translate into Spanish any documents that must be read
and/or completed by study subjects, and produce health-education
Our Director is GCP-certified with many years of experience.
Our team of language professionals has worked for many years in the healthcare field.
This allows us to ensure that all translated
documents meet IRB requirements. We have special expertise
in translating consent forms, due to their importance in protecting
the welfare and information needs of the subject. We are also
experts in the translation of research questionnaires, giving
great attention to precision in the transfer of meaning, facilitating
data collection and assuring validity and comparability of
results across languages. The STC is setting the standard
of excellence in translation by creating quality documents
that enhance the ability to provide culturally and linguistically
Contact the STC: Spanish-Translation@ColumbiaClinicalTrials.org
Instructions for sending documents to the STC
was established by the Clinical Trials
Office and is directed by Robert B. MacArthur, PharmD. It
has served the varying needs of Columbia University Medical
Center investigators and their sponsors since 1995.
Research Medication Dispensing and Manufacturing: The
Research Pharmacy is equipped to manufacture, package, dispense,
blind, randomize, and manage all dosage forms (tablets, capsules,
liquids, suspensions, sterile solutions for injection, ointments,
creams, etc.) for all routes of administration. Additionally
the Research Pharmacy will handle drug ordering, inventory,
accountability, and return shipments for study drug products,
including controlled substances and devices. The Research Pharmacy
can also assist in the development, testing (sterility, pyrogens,
stability, compatibility), and manufacturing of novel sterile,
and non-sterile product formulations.
Pharmacokinetic Study Design and Support: The experienced
staff of the Research Pharmacy has assisted with the performance
of well over 100 pharmacokinetic studies involving a wide range
of therapeutic areas. They are available to assist with the
design, and implementation of studies, and can also analyze
The Biostatistics Consulting Service (BCS) is a clinical research consulting
service, supported in part by the CUMC/NYPH Clinical Trials Office and
provided free to all clinical researchers on the Columbia University Health
Sciences campus. The BCS is staffed by members from the
Department of Biostatistics
Mailman School of Public Health.
The BCS staff members
have extensive expertise in clinical trials as well as other experimental designs.
The members of the BCS can provide state-of-the-art guidance on statistical
analysis and study design for all stages of research.
Investigators needing statistical advice or assistance in data analysis are typically
accommodated within a few days of their request. The consultation process
begins with an initial meeting to discuss the project. If the statistical needs of the
project can be addressed within approximately 5 hours, the BCS will provide the
statistical support for the project. If based on the meeting it is determined that
longer-term support is required to, say, write a scientific paper or to produce a
grant application, the project will be referred to other faculty members in the
Department of Biostatistics for co-authorship or salary support (via serving as a
co-investigator on the grant proposal). To make an appointment, please contact
Shing Lee at