CTSA Clinical Research Unit (CRU)
Cleveland Clinic
CRU
INVESTIGATOR
MANUAL
Credit on Publications: All publications that result from utilization of any of the CRU
resources should cite the grant as a contributing source of support and indicated the
CRU grant number, “CTSA 1UL1RR024989”
GCRC Investigator Manual – Rev. 6.7.2005
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INDEX
Page
Number
Mission Statement
Contact Information
CRU Operational Flow
Technical Resources
Administration
Application
CRU Advisory Committee
Resource Council
Subject Categories
Research Subject Advocate
CRU Resources
Nursing
Core Laboratory
Informatics Core
Biostatistics
Services
Nutrition
Pharmacy
Study Initiation
Required Documents
Study Execution
Scheduling
Medical Record Management
Scheduling Request Form
Admission Procedures
Annual Reporting
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3
4
5
7
7
8
9
10
12
12
15
15
16
17
18
19
20
20
21
22
23
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MISSION STATEMENT
The mission of the CTSA Clinical Research Unit (CRU) at CCF and the Cleveland Clinic
Lerner College of Medicine of Case Western Reserve University (CCLCM) is to facilitate
and enhance the performance of clinical research so as to help understand human
physiology, translate basic research into patient care, and develop new therapies. This
is done through the provision of core support for the design, implementation, and
analysis of clinical studies. This includes inpatient and outpatient research space, the
expertise of research nurses, a laboratory core, informatics core & biostatistics core,
Research Subject Advocate (RSA), and research subject support. The CRU is also
committed to providing an environment that ensures the training of the next generation
of clinical investigators through support of young investigators and medical students.
CONTACT INFORMATION
Charlotte Bhasin, MOT, OTR/L
Administrator / M51
216/444-5113
Fax: 216/636-3367
bhasinc@ccf.org
Kay D. Stelmach, RN, RTT
Nurse Manager / M51
216/444-3588
Fax: 216-636-3367
stelmak@ccf.org
Jackie Soos
Department Coordinator / M51
216/445-6018
Fax: 216/636-3367
soosj@ccf.org
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CRU OPERATIONAL FLOW
Pre-application Assistance - Contact CRU at (216) 444-5113
Complete
PI submits completed application with protocol and budget to CRU
Administration to be reviewed for completeness. There, a database log and
project file will be created.
Copies of the application are distributed to
RSA and Biostatistics for review.
Not approved
Incomplete
PI will be contacted by
CRU administration for
missing info.
CRU Workgroup Overview: RSA, Biostatistics, Core Lab, Nursing, Informatics. The WorkGroup will
review the project, based on each respective WorkGroup member’s expertise, to identify any potential
issues or problems with the project.
Approved
Not approved
The application is forwarded to the CRU Advisory Committee (GAC)
Chairman who will assign two GAC members to review and score the
project based on scientific merit. Once completed, the reviews are presented
before the GAC for further consideration.
Comprised of hand-appointed CCF staff physicians of diverse specialties &
expertise, the GAC considers the project’s scientific merits and assigns an
overall score based on the reviews, scores, RSA and Biostatistics
comments.
Favorable Score
Contact PI to answer questions or
resolve issues.
Unfavorable Score
Depending on the outcome, the PI will receive a formal letter requesting to either
revise their project, or that the project has been rejected outright. All reviews
(with the reviewer’s made anonymous) are forwarded to the PI. If a revision is
requested, then a designated mentor may be assigned to assist. All revisions must
be received by the CRU within 90 days, or a new application must be submitted.
Project is presented at Resource Council for
approval of requested resources.
Requested
resources approved.
Requested
resources denied.
A formal letter is sent to the
PI to reconsider resources.
A formal letter is drafted, signed by the CRU administrator, and sent to the PI-- listing the
approved resources as requested in the original application protocol.
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CRU TECHNICAL RESOURCES
The resources listed below are the not for the sole purpose of the listed disciplines, but
are common CRU procedures available for current and future projects.
Endocrinology/Gastroenterology
 Fat Balance Studies
 Indirect Calorimetry
 Glucose Tolerance Test
 Glucose/Insulin Clamp Studies
 10 min and 3 hr Frequently Sampled Glucose Tolerance Test
 Continuous Insulin Infusion
 Endoscopy
 Nutritional assessment
Cardio-pulmonary
 Exercise Stress Testing - cycle ergometry or treadmill
 EKG
 Bronchoscopy
 Pulmonary Function Testing
 Telemetry
 Plethysmography
Pediatrics
 Pediatric IV Access and Phlebotomy
 Pediatric Advanced Life Support
General







Pharmacokinetic Studies
Long-Line Blood Draws (Blood Sparing Technique)
Continuous Pulse and BP Monitoring
CADD Pump Infusion
Conscious Sedation
Central Line Site Care
Peripheral Line Access and Maintenance
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Project Management Support
CRU Equipment
 Blood gas and metabolite/electrolyte analysis (ABL 735)
 Centrifuges
 Fume hood
 Laminar Hood
 Incubators
 Microscopes
 PCR machine
 Electrophoresis equipment
 Freezers (-20c, -80c)
 4c unit
 Elutriator
 Blood draw capability in both M51 and NC20
 Flexible bronchoscopy
 Flexible endoscopy
 Harvard Dual Infusion Pump
 Plethysmography
 Indirect Calorimetry
 Pulmonary Function with Body Box
 Pulse Oximetry
 Negative Inspiratory Force Meter
 Telemetry
 Cycle ergometer
 Treadmill
 Doppler
 Bioelectrical Impedance
 Plate reader
 Spectrophotometer
 Gel documentation system
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ADMINISTRATION
The CRU administrative office is located on the 5th floor of the M building, adjacent to
the in-patient/out-patient unit. Grant management for the CRU is supported by the
Administrative Director (AD) and a Program Assistant.
Center administration for CRU protocols includes:
CRU application process
Budget and administrative review of CRU application
Billing procedures, bill review and adjustments
CRU Applications
General CRU application
Healthy donor lab draw only application
CRU/RPC CREFF application
These can be accessed through the CRU website http://info.research.ccf.org/dcr/gcrc/
or by contacting the administrative office. Administrative personnel will assist the
investigator and/or the research coordinator with any questions.
An application to the CRU can be made at any time during the IRB approval process.
(CRU studies cannot be initiated until full IRB approval)
The CRU team reviews applications in order to determine appropriate use of the CRU
resources. Weekly operation meetings are held to review applications for funding
source, bioethics, biostatistics, clinical and core lab resource issues. At this time
recommendations are made to move the project forward for scientific review by the
CRU General Advisory Committee (GAC) or tabled and returned to the Principal
Investigator (PI) for recommended revisions.
* Investigators may find it beneficial to meet with the CRU staff prior to submission of NIH grants
CRU General Advisory Committee (GAC)
The GAC is composed of a cross section of faculty members who are familiar with
broad elements of research activity. Each project is reviewed and scored for scientific
merit using the NIH review process. Applications to the CRU are judged on the quality
of their science. NIH funded applications are given first priority.
The General Advisory Committee (GAC) meets the 1st and 3rd Wednesday of each
month. Any study initiated on the CRU must have (GAC) approval, or the written
approval of the CRU Program Director, in the case of an expedited approval. If the
GAC has recommended revision of the protocol as conditional to approval, the
recommended revision(s) must be submitted and acknowledged as satisfactory by
either the Administrative Director, or the GAC reviewer, as specified in the GAC
correspondence. All review comments are sent to the PI. Correspondence is sent to the
PI with the GAC comments.
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Resource Council
Once a project has been approved for scienticific merit, the resource council meets to
review and assigns requested resources. NIH funded applications are given first priority.
Resource Council responsibilities include allocation of CRU resources.
CRU Resources
 Nursing
o Nursing staff is trained to support projects through complex research
observations and precise collections of specimen while providing
exemplary subject care
 Core lab
o Perform complex laboratory procedures to provide reliable and
accurate analysis of research specimens for CRU approved projects
 Ancillaries
o An Ancillary is defined as a service routinely available through hospital
departments for all patients. The CRU supports ancillary tests that are
required for research purposes only that are outside of standard of
care. CRU support is not available for services funded by the
investigator’s grant, professional fees, lab work performed in the
investigator’s lab, experimental tests done in a research laboratory
outside of the CRU Core Lab or Imaging procedures.
Resource council meets the 2nd and 4th Wednesday of each month and is comprised of
the CRU grant PI, program directors and CRU administrative team. Correspondence will
be sent to the PI outlining approved CRU resources. Resources are reviewed and
awarded on a yearly basis.
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CRU SUBJECT CATEGORIES
The CRU grant guidelines describe three administrative categories, which are used for
all research protocols. A general description of each category is found below, with the
billing method used. Billing instructions for all patients should be specified on the CRU
reservation forms. Questions regarding these categories should be directed to the
Administrative Director of the Administrative Program Coordinator.
Research Patients - Category ‘A’
Research inpatient days or outpatient visits in an investigator-initiated study utilized
solely for research purposes. All patient care costs are the responsibility of the CRU
grant and the investigator’s research funds, with the exception of some Medicare
Qualifying Clinical Trials (MQCT) that bill routine care charges. CRU services are fully
supported for approved ‘A’ studies
Research Service Patients - Category ‘B’
Research inpatient days or outpatient visits that involve patients admitted for diagnosis
or treatment based on established standards of care. The CRU or investigator is
responsible for research-related charges, while non-research care is billed to a third
party carrier or the patient. Billed by CCF to a third party payor or the patient, EXCEPT
for research related charges, which are applied to the CRU’s or the investigator’s
research accounts before the bill is sent.
Industry-Initiated Projects - Category ‘D’
Inpatient days and outpatient visits utilized for an industry study. Charges are the
responsibility of the investigator and the sponsor. CRU approved resources are billed
directly to the investigator’s CCF research account for the industry supported study.
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RESEARCH SUBJECT ADVOCATE (RSA)
Under the guidance of the National Institutes of Health National Center for Research
Resources (NCRR), this program is responsible for guarding the welfare of research
participants during all phases of research activity to include study design, participant
recruitment and enrollment, and research intervention and data collection. Accordingly,
the RSA Program assists research subjects as well as members of the CRU research
team.
Specific functions include
 Assisting research investigators with protocol design, to include
inclusion/exclusion criteria, recruitment plans, risk/benefit analyses and
subject compensation.
 Assisting research investigators with the formulation and creation of Data and
Safety Monitoring Plans (DSMPs) and Data and Safety Monitoring Boards
(DSMBs).
 Auditing studies to ensure compliance with human subjects protections
regulations.
 Monitoring adverse events.
 Evaluating conflict of interest disclosures.
 Facilitating research ethics training for all key study personnel.
 Witnessing or assisting the informed consent process.
 Providing study information to research subjects.
Research Investigators
Please contact the RSA Program office for assistance with protocol and data safety
monitoring plan preparation, or concerns you may have about research participation
and human research regulations. All protocols must be reviewed and approved by the
RSA Program, as well as the General Advisory Committee (GAC) and the CCF
Institutional Review Board (IRB), before the research project may begin.
We advise you submit your CRU application first, rather than your IRB application. By
submitting your protocol to the CRU first, your protocol, consent form and Data Safety
Monitoring Plan will be reviewed and red-lined by the Research Subject Advocates.
The RSA is 100% focused on research ethics and research subject protections. By
making the changes suggested by the Research Subject Advocates, usually your
documents will satisfy IRB research ethics requirements.
Additionally, ALL adverse events (expected and unexpected) must be reported to the
RSA Program office. Unexpected adverse events must be IMMEDIATELY reported to
either Dr. Katrina Bramstedt or Ms. Katy Kassimatis either in-person, by phone, or by
pager. These CRU reporting requirements are in addition to those of the IRB.
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RSA Contact information
Carmen Paradis M.D., M.A.
Director, CRU Research Subject Advocate Program
Bioethics, Associate Staff
JJ60
216-445-2767
Fax 216-444-9275
Pager 28848
paradic@ccf.org
CRU Links:
RSA policies & forms (website under construction, please contact the RSA directly)
CRU policies & forms (website under construction, please contact the CRU directly)
IRB policies & forms (http://intranet.ccf.org/irb/general/IRBPoliciesAndProcedures.doc)
CCF Dept. of Bioethics (http://www.clevelandclinic.org/bioethics/)
Other Links:
FDA (www.fda.gov)
NIH (www.nih.gov)
OHRP (http://ohrp.osophs.dhhs.gov)
Belmont Report (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm)
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RESOURCES
The CRU resources include a 7-bed research inpatient/out-patient unit located on the
5th floor of the M building (M51). The CRU, funded by NCRR, provides a controlled
environment to do patient-oriented research.
Nursing Resources
Experienced research nurses staff both the inpatient and outpatient areas. Nurses are
experienced in a variety of specialties and with continuing education maintain expertise
to support a wide range of studies from various disciplines. The research nursing staff
is familiar with initiating and maintaining time-oriented research procedures ranging
from the simple to complex. Annual competency-based training insures proficiency in
research procedures. Additional training for research-specific procedures is instituted as
new studies are initiated.
Procedure rooms with capability for bronchoscopy, PFT, endoscopy, muscle biopsy,
and other research modalities are located adjacent to the patient rooms. A Phlebotomy
satellite station is located on the second floor of the Lerner Research Institute for
studies using healthy donor samples. Core hours of the unit are 8:00am to 5:00pm.
Alternative staffing is determined based on specific protocol needs.
Nursing Contact Information
Kay D. Stelmach, RN, RTT
Nurse Manager / M51
216/444-3588
Fax: 216-636-3367
stelmak@ccf.org
Core Laboratory Resources
The CRU Core Laboratory is located in Room M51-23. The Core Laboratory facility has
capability for molecular biology, specimen processing and analytical work. In addition,
the CRU is able to support some work done through the Imaging (microscopy), Flow
Cytometry, and Mass Spec cores.
The Core Laboratory is currently authorized and equipped for the use of radioactive
materials.
The primary functions of the Core Laboratory are to:
 Provide technical support for sophisticated clinical research assays
 Develop or validate new laboratory analysis methods
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The Core Lab can provide manpower for specific laboratory procedures, but resources
for supplies are limited. The Core Lab should be contacted to discuss the costs of
specific tests.
Investigators are strongly encouraged to discuss experimental details with the Core
Laboratory prior to the beginning of a study to ensure that the Core Laboratory can
meet study needs appropriately.
Investigators should contact the core lab about the possibility of adding or supporting
other laboratory assays not specified here.
Specimen Processing
The Core Laboratory can perform minimal to complex specimen processing. Among its
services are:
 Blood, serum, plasma or urine aliquots
 DNA and RNA Isolation
 Elutriation for large quantity blood cell separation
o Lymphocyte and Monocyte isolation
Research Assays
The Core Laboratory can provide assays for research purposes.
 Blood profile
o pH
o Hematocrit
o Hemoglobin
o Oximetry
o Glucose
o Lactate
o Bilirubin
o Potassium
o Calcium
o Chloride
o Sodium
 ELISA and colorimetric assays
CRU support for the Imaging core includes the following services
 Confocal microscopy
 Confocal microscopy with assistance
 Digital image analysis
 Digital microscopy with assistance
 Image processing
 Live video microscopy 6-24 hours
 Live video microscopy up to 6 hours
 LMD (laser microdissection)
 LMD with assistance
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CRU support for the Flow Cytometry Core includes the following services
 Acquisition and Analysis
o FACScan – (analysis)
o FASCVantage – (Sterile cell sorting)
o LSR – (Multi-color analysis)
 Consultation
o Experimental Design
o Interpretation
o Troubleshooting
Mass Spec Core
 Please inquire with the core lab regarding CRU-supported mass spec assays.
CRU Core Lab Policies
Subject demographic information is required for year-end reporting to the NIH. If
demographic information is not provided to the laboratory, all work must be billed to the
investigator’s grant. The CRU cannot support work for which no demographic
information is provided.
Samples must be received in an organized and understandable manner. All samples
must be clearly labeled, accompanied by a spreadsheet listing the sample identification
along with demographic information.
The Core Lab will inventory samples. Any samples that do not match the requisition will
be returned to the investigator.
Specimen Storage
The Core Laboratory has access to a 4°C refrigerator, one upright –20°C and one -70°C
freezer for short-term specimen storage. All refrigerators and freezers are equipped
with centrally monitored alarm systems for efficient and accurate temperature control.
The Core Lab does not provide long-term storage of samples.
Specimen Shipment
The Core Laboratory has the capability to ship out samples either 1) Ambient, 2) Ice
packed, or 3) Dry Ice to designated laboratories. Investigators are asked to provide
shipping labels that include an account number. The Core Lab cannot pay for shipping
charges.
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Core Laboratory Contact Information
Teresa Markle, BS
CRU Core Lab Research Technologist / M51
216/445-5470
Fax: 216-636-3329
marklet@ccf.org
Informatics Core Resources
It is anticipated that CRU clinical investigators publish their scientific findings. In order to
produce quality data collection, the bioinformatics team explores and implements
technologies for design of data management tools and methodologies.
Informatics Core Contact Information
Chuck Trunick
CRU Systems Analyst / M51
216/445-6933
Fax: 216-636-3367
trunicc@ccf.org
Biostatistics Resources
The CRU biostatisticians are available to assist investigators with the design, analysis
and presentation of research studies. This includes defining an appropriate study design
and sample size to insure that the investigator’s research questions can be reliably
answered; defining and coordinating appropriate data analyses; and helping with
abstract, manuscript, and presentation preparation.
Biostatistics Contact Information
James Bena, MS
Senior Biostatistician / Wb4
216/445-2336
benaj@ccf.org
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SERVICES
Nutrition Services
The CCF CRU does not have a full time Research Dietitian. CRU resources for
Nutritional studies can be requested from an associated CRU to provide scientifically
controlled dietary regimens needed for inpatient and outpatient studies.
Services available to support the dietary components of the research protocols
 Energy balance/Body Composition Assessment
 Bioelectrical Impedance including single and multi-frequency
 Basal and Thermal Energy Expenditure measurements
Controlled Diets
Diets are specifically designed to meet the research objective and nutrient requirements
of the subject. The meals are provided to the subjects and are rigidly controlled. These
diets are provided to inpatients in the hospital or on an outpatient basis. The subject
can pick meals once a day. Diet compliance is monitored on a daily basis.
Nutrient Analysis
Nutrient analysis can be performed based on 24-hour diet history or Food Frequency
according to the particular protocol’s needs.
Weighed Diets
Diets with known nutrient content are served to the subjects and actual nutrient
composition of the diets is analyzed after they have consumed the meals.
Nutritional Instruction
Diet instructions to meet the objective of the study and follow up for dietary compliance
are provided.
Meal Service
Subjects who are at the CRU for more than 4 hours will be provided with meals.
General and routine diets for subjects without diet modifications for research purposes
will receive their meals from the main kitchen. All meals requiring diet modifications for
research will be under the direction of a dietician.
Contact the Administrative Director for an application for dietary needs from an adjacent
CRU.
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PHARMACY
Contact John Petrich, RPh Investigational Drug Studies Coordinator regarding all nonchemotherapeutic drugs that will be stored and dispensed by the pharmacy. Contact
Sam Calabrese, RPh for all chemotherapeutic drugs that will be stored and dispensed
by the pharmacy.
To ensure that all drug-dispensing details are verified, involve the research pharmacy
early in your planning process. Your grant will be responsible for pharmacy start up
charges and for charges associated with preparing each dose of your study drug. Make
certain that drug is available prior to scheduling the first subject
Study drug not requiring special preparation and storage can be stored in the secure
site on the CRU. Conte Suttles, CPhT, will be making quarterly QA visits to the CRU. All
study drugs will be logged.
Daily Medications
Category A patients that will be staying overnight in the CRU will be asked to bring their
prescription medications to their research visit. These medications will be verified with
the physician orders by a registered pharmacist and labeled. The medications will be
kept in the CRU Pyxis system and dispensed as ordered.
Pharmacy Contact Information:
John Petrich, RPh
Investigational Drug Studies Coordinator / Hb03
216/444-1128
Fax 216-445-5554
Pager 21586
petricj@ccf.org
Sam Calabrese, RPh
Pharmacy / R41
216/444-8068
Pager 24525
calabrs@ccf.org
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STUDY INITIATION
Required Documents
Before initiating a study, it must have full IRB approval for the protocol version, and all
current amendments that are to be initiated. A copy of the IRB approval letter for the
study, and a clean copy of all IRB stamped and dated Consent documents must be
received in the CRU administrative office.
In order to meet NIH requirements for training in human subjects’ protection, all
Principal Investigators and key personnel of clinical research projects must complete
the University of Miami’s CITI (collaborative IRB training initiative) web-based
course. A copy of the grade book and completion report for all active research
personnel must be submitted to the IRB with the IRB study application. The CITI course
is accessible at www.citiprogram.org
If the final budget was not available at the time of GAC review and approval, a final
budget must be reviewed and approved by the Administrative Director. Significant
budget changes not discussed with the Administrative Director could result in a delay in
the initiation of the study.
If the protocol will be using a research memo account, the memo account must be
established and activated prior to requesting a CRU reservation for the first patient. The
memo account number should be communicated to the Administrative Director or the
CRU unit secretary. If the protocol is category ‘D’, the research account application
should accurately list CRU charges, and must be reviewed by the CRU Administrative
Director before the application is submitted to the Office of Research.
A Data and Safety Monitoring Plan must be submitted and approved by the CRU,
RSA and the GAC prior to study initiation. If your study has a Data Safety and
Monitoring Board, the membership list and charter must be submitted with your
application for GAC review.
Questions regarding required documents, assistance with clarification or additional
information about the application process should be directed to the CRU Administrator,
at 216/444-5113.
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Study Execution
Prior to the initiation of a study on the CRU, a protocol meeting is recommended. This
provides an opportunity for CRU staff and the investigator to discuss the study
procedures, lab techniques, case report forms, source documentation and supply needs
for the study. Arrangements will be made to conduct the protocol meeting on a day
when the greatest numbers of staff that will be involved with your study are available.
To arrange a protocol meeting contact the Clinical Nurse Manager or the CRU
Administrator.
Investigators and their research team are strongly encouraged to discuss experimental
details and attend a meeting with the Core Laboratory prior to the beginning of a study
to ensure that we can meet study needs appropriately and that all details for specimen
processing are clear. Standard operating procedures (SOPs) for specimen processing
are written to ensure that all specimens are collected and processed in accordance with
the approved instructions specific for each protocol
The CRU has developed some preprinted order sheets to assist physicians in the
admission process. The principal investigator should prepare physician’s orders and, if
needed, a flow sheet for the study. Orders should be kept simple and straightforward;
outlining what is to be done by the nurse (e.g. blood draws, frequency of vital signs,
medication administration and physicians to be notified in case of emergency.
If blood specimens are to be drawn, please include the type of tube in which the
specimen should be drawn, and any special handling instructions. If special processing
is needed, provide specific instructions. Include which lab the specimens are to be sent
or will be picked up by you or a designee. The Principal Investigator must sign a
finalized copy of orders
Flow sheets can be devised for studies when serial specimens are to be obtained,
medications are to be given, or procedures are to be performed at very specific time
points over the course of the patient’s visit. A well-devised flow sheet will enable all
staff to easily determine procedures at a glance. This minimizes the chance of mistakes
and ensures that the study is run properly and clean data is collected.
Electronic charting is available in the CRU. Once the orders and flow sheets have
been revised and approved by the principal investigator, a smart text is often created to
capture all of the study procedures and provide solid source documentation.
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Scheduling
All appointment requests should be faxed to (216) 636-3329 using the attached
Scheduling Request Form.
Appointments are scheduled on a first come, first serve basis. Booking an appointment
is done based on availability of space, nursing and lab personnel. When booking an
appointment, have at least two dates in mind. As space and staffing is limited, please
be flexible when arranging dates with your subjects.
Should scheduling conflicts arise “A” studies supported by NIH funding are given priority
when scheduling visits.
NIH “A” studies can override another booking of an
appointment is made 7 days in advance of the desired date and the “bumped” booking
is not on a fixed schedule. It is suggested that to request that recurring appointments for
an entire protocol cycle.
Medical Record Management
Inpatient records will be kept using CCF Admission packet and Nursing Progress
Record. All assessments and charting will follow CCF policy.
Outpatient visits are recorded in Epicare. Study specific smart texts are developed to
capture all study procedures and all pertinent study data. Hardcopy source documents
will be placed in study binders and returned to the study coordinators. All Investigators
are responsible for their research records. There is no storage space available on the
CRU for case report forms or research files.
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CCF CRU Research Subject
Scheduling Request Form
(Fax this completed form to 216-636-3329)
Subject Name ___________________________________________
CCF# ____________________
Primary Investigator/phone ____________________________________
Study Coordinator/pager______________________________________
Protocol/ IRB#__________________________________________________
Type of Visit:
_______Inpatient Visit
_______Outpatient Visit
Diagnosis: (for admissions) _______________________________________
Date(s) Requested _________________________________________
Admission time Requested __________________________________
Special Needs ____________________________________________
Comments:
Requested By ________________________ Fax Number ___________________
Phone ________________________ Pager _________________________
Email ____________________________________
Your request is not confirmed unless you get a return call, email or fax from the CRU.
Please call 445-8526 if you do not get a response within 24 hours.
CRU to fill in information below:
_________________ was notified via ______________ of the following confirmation
information:___________________________________________________________________
____________________________________________________________________________
_______________________________________________________________
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Admission Procedures
Category “A” subjects requiring an overnight stay will be admitted to M51. Category “B”
subjects will be evaluated on the complexity of their standard of care needs and
admitted to M51 unless subject care and safety could best be met in another care area.
CCF standard admission charting will be completed on all patients on M51 at midnight.
Admissions will not be arranged if the PI or his study team cannot provide coverage.
CRU Admission policy is attached.
CRU Nursing Admission Policy
*Documentation Requirement for Inpatient Admission to the CRU
Patients who are admitted to the CTSA Clinical Research Unit require a high standard of
documentation by virtue of their voluntary participation in a research study.
Physician Documentation Requirement
1.
All subjects admitted to the CRU for participation in a research study will have
documentation of a recent medical history and physical on the chart before the initiation
of any research procedures. The history and physical must have been obtained or
verified within the 30 days prior to admission.
2.
All subjects will have signed study-specific standardized research orders on the chart
before the initiation of any research procedures.
3.
All subjects will have a study-specific, IRB-stamped consent form on the chart before the
initiation of any research procedures.
a.
The consent form must be the most current IRB-approved version.
b.
The consent form must be signed and dated by either the subject (or guardian)
and the physician or study coordinator witness on the same date.
c.
The investigator’s team is responsible for providing a copy of the consent form
for the chart for subsequent study visits if the CRU does not have a copy.
4.
All subjects must have a daily physician visit note entered into the chart for every 24
hours that they are on the CRU. A note must be entered upon discharge describing the
subject’s response to any study drugs or testing agents administered, including a
complete description of any adverse events and required treatments.
5.
Any patient on M51 at midnight is considered a CRU admission and will require
the above documentation.
CRU Nursing Documentation Requirement
1.
2.
3.
4.
The CRU nurse assigned to a patient admitted to the CRU for participation in a research
protocol will complete the CCF adult or pediatric Nursing Admission Assessment Form,
medication records, and all other baseline documentation required according to CCF
Nursing Policies, prior to the initiation of any research study procedures.
In addition, the nurse will provide narrative documentation of the subject’s understanding
of the research protocol, and willingness to participate.
CRU Nurses will document narrative observations on each research subject once every
24 hours.
All protocol-specific study flow sheets will be completely and legibly filled in with black
ink to be used as source documentation for the research protocol.
GCRC Investigator Manual – Rev. 6.7.2005
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ANNUAL REPORTING
The CRU is required to submit an Annual Report of scientific progress and an annual
financial status report within 90 days after completion of the grant year. These reports
are reviewed by NIH and are used for planning and evaluation. Through these reports,
NIH is kept apprised of current research activities and accomplishment at the CRU for
Congressional reports and budget justifications and other reports.
Subject enrollment demographic data will be provided to the CRU on a quarterly basis.
This information will be reported on the annual report.
The primary investigator will be requested to submit a project summary and a list of
publication(s) resulting from the utilization of the CRU.
GCRC Investigator Manual – Rev. 6.7.2005
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