6/3/2015 GCRC's and the BIRN 1 General Clinical Research Centers and the BIRN Paul Shragg, M.A. UC San Diego, GCRC

04/18/2304/18/23 GCRC's and the BIRNGCRC's and the BIRN 11

General Clinical Research Centers General Clinical Research Centers and the BIRNand the BIRN

Paul Shragg, M.A.Paul Shragg, M.A.

UC San Diego, GCRCUC San Diego, GCRC


GCRC’s GCRC’s

• GCRC program started in 1959GCRC program started in 1959• Computing component added in 1981/82Computing component added in 1981/82• Funded by the Division for Clinical Research Funded by the Division for Clinical Research

Resources (DCRR) of the NCRR of the NIHResources (DCRR) of the NCRR of the NIH• GCRC grant supports the components essential GCRC grant supports the components essential

to clinical research: operating expenditures, to clinical research: operating expenditures, hospitalization and ancillary laboratory costshospitalization and ancillary laboratory costs

• Most GCRC’s are in a 5 yr competitive grant Most GCRC’s are in a 5 yr competitive grant cycle process (i.e. re-compete / site visited every cycle process (i.e. re-compete / site visited every five years)five years)


GCRC’s GCRC’s (What are they?)(What are they?)

GCRC’s are a national network of more than 80 centers that provide optimal settings for

medical investigators to conduct safe, controlled, state-of-the-art, in-patient and out-patient studies of both children and

adults.



GCRC’s provide clinical investigators the infrastructure needed for the conduct of

high quality “patient oriented” clinical research in order to facilitate the

bidirectional translation of both basic and clinical research.



We are a research resource for clinical researchers providing the infrastructure

needed to conduct clinical research through a combination of services and

“Cores“


GCRC Cores and ServicesGCRC Cores and Services


GCRC Services and CoresGCRC Services and Cores

• Administrative ServicesAdministrative Services• Provides help in applying for resources Provides help in applying for resources • Provides help with IRB and human subject concernsProvides help with IRB and human subject concerns• Cost analysis of protocolsCost analysis of protocols• Keeps census dataKeeps census data

• NursingNursing• Provides expert research nursing assistanceProvides expert research nursing assistance

• BionutritionBionutrition• Provides special meals and assistance on protocols Provides special meals and assistance on protocols

investigating metabolic disorders or other protocols with a investigating metabolic disorders or other protocols with a nutritional componentnutritional component

• Core LabCore Lab• Performs special purpose assays for GCRC investigatorsPerforms special purpose assays for GCRC investigators



• BiostatisticsBiostatistics• Provides help in study designProvides help in study design

• Power Analysis, data collection methods, formulating testable Power Analysis, data collection methods, formulating testable hypotheseshypotheses

• Provides help with data analysisProvides help with data analysis• Descriptive and InferentialDescriptive and Inferential

• Helps with presentation of resultsHelps with presentation of results

• RSARSA• Tracking of adverse eventsTracking of adverse events• Patient advocacyPatient advocacy

• Oversee and help create DSMP’sOversee and help create DSMP’s• Review consent forms and works with and in conjunction with Review consent forms and works with and in conjunction with

the local IRBthe local IRB


GCRC Services and Cores GCRC Services and Cores

• Laboratory for Sleep and ChronobiologyLaboratory for Sleep and Chronobiology• 3 sleep bedrooms at the Medical Center3 sleep bedrooms at the Medical Center• 5 sleep bedrooms at the VA5 sleep bedrooms at the VA• Grass and Embla Sleep recording systemGrass and Embla Sleep recording system• Assistance with planning sleep aspects of research protocolsAssistance with planning sleep aspects of research protocols• Full PSGFull PSG• Sleep study scoringSleep study scoring• Help with data managementHelp with data management


GCRC Services and Cores GCRC Services and Cores

• Informatics CoreInformatics Core• Provides support to a number of different GCRC Provides support to a number of different GCRC

investigators and research projectsinvestigators and research projects• The level of support differs from protocol to protocolThe level of support differs from protocol to protocol

• Data base support, developing/serving software tools, Data base support, developing/serving software tools, statistical support, desktop support/connectivity/network statistical support, desktop support/connectivity/network issues, bioinformatics, help developing forms and web issues, bioinformatics, help developing forms and web based tools…end user supportbased tools…end user support

• All support the computer needs of their GCRC’s CoresAll support the computer needs of their GCRC’s Cores• LIMS, real time data collection, labeling programs, data LIMS, real time data collection, labeling programs, data

base support (upgrades and backups of commercial base support (upgrades and backups of commercial products), networking issues, CAMP/ARPproducts), networking issues, CAMP/ARP



• Informatics Core (Con’t)Informatics Core (Con’t)• Most are one person shopsMost are one person shops

• Each with their own interests and strengthsEach with their own interests and strengths• Each responds to the unique research interests of their Each responds to the unique research interests of their

institution institution • Different hardware configurations between sitesDifferent hardware configurations between sites

• Different servers and OS’s (Windows, UNIX, MAC)Different servers and OS’s (Windows, UNIX, MAC)• Some support a user room with workstations and Some support a user room with workstations and

other hardware (Scanners, etc.)other hardware (Scanners, etc.)


GCRC’sGCRC’s

• Every GCRC has a Scientific Advisory Every GCRC has a Scientific Advisory Committee (SAC)Committee (SAC)

• Program director is a Program director is a member• Other expert MD’s and PhD’s sit on the committee • Protocols are submitted requesting different Protocols are submitted requesting different

resources of the GCRCresources of the GCRC• Protocols are reviewed, ranked and appropriate resources Protocols are reviewed, ranked and appropriate resources

are allocatedare allocated• Most, but not all, request nursing services, in addition to Most, but not all, request nursing services, in addition to

other servicesother services• Some are informatics and/or biostatistics only protocolsSome are informatics and/or biostatistics only protocols


GCRC’s GCRC’s

• Each GCRC is unique and eclecticEach GCRC is unique and eclectic• Each GCRC reflects the host institutions strengths, Each GCRC reflects the host institutions strengths,

interests, and needs of its researchersinterests, and needs of its researchers• Multi disciplinary research settingMulti disciplinary research setting

• Many commonalities exist between GCRC’s Many commonalities exist between GCRC’s

• Most GCRC’s provide the same services and CoresMost GCRC’s provide the same services and Cores• Many GCRC’s are studying the same diseasesMany GCRC’s are studying the same diseases


The UCSD GCRCThe UCSD GCRC

• 10 Bed Inpatient Unit (Medical Center, Hillcrest)10 Bed Inpatient Unit (Medical Center, Hillcrest)• Outpatient Facility (Medical Center and Campus)Outpatient Facility (Medical Center and Campus)• Specialized research nursesSpecialized research nurses• Core Lab Core Lab • Metabolic Kitchen (Research Dietitians)Metabolic Kitchen (Research Dietitians)• Laboratory of Sleep and ChronobiologyLaboratory of Sleep and Chronobiology• Informatics and Biostatistics CoreInformatics and Biostatistics Core



• Many departments utilize our GCRCMany departments utilize our GCRC• PsychiatryPsychiatry

• Women’s health issues (e.g. PMDD, PMS)Women’s health issues (e.g. PMDD, PMS)• Sleep deprivation and brain functionSleep deprivation and brain function• Genetic linkage and affective disorderGenetic linkage and affective disorder• Stress physiology hormonesStress physiology hormones

• Medicine Medicine • DiabetesDiabetes

• Type I and Type IIType I and Type II

• Hypertension and blood pressure controlHypertension and blood pressure control



• PediatricsPediatrics• NASHNASH

• NeurosciencesNeurosciences• Inborn error of metabolism – Lactic Acidemia, Leucine Inborn error of metabolism – Lactic Acidemia, Leucine

metabolism metabolism

• Reproductive MedicineReproductive Medicine• PCOSPCOS

• For a current list of all active GCRC protocols at For a current list of all active GCRC protocols at UCSD, log onto UCSD, log onto http://http://gcrc.ucsd.edugcrc.ucsd.edu and click on and click on “Active Studies”“Active Studies”



• Some Imaging Studies at UCSDSome Imaging Studies at UCSD• Camellia Clark, M.D.Camellia Clark, M.D.

• fMRI and DepressionfMRI and Depression• Sleep Depivation, EEG, and fMRI in DepressionSleep Depivation, EEG, and fMRI in Depression

• Sean Drummond, Ph.D.Sean Drummond, Ph.D.• Sleep Deprivation and Brain Function in Older AdultsSleep Deprivation and Brain Function in Older Adults• Effects of Total Sleep Deprivation and Recovery Effects of Total Sleep Deprivation and Recovery

Sleep on Cognitive Performance and Brain FunctionSleep on Cognitive Performance and Brain Function


The UCSD Informatics CoreThe UCSD Informatics Core

• Support 3 Servers running Windows OSSupport 3 Servers running Windows OS• IIS Server – Serving our web page and the RSA IIS Server – Serving our web page and the RSA

database and soon will host a UCSD Statin Study web database and soon will host a UCSD Statin Study web page with a web based survey attachedpage with a web based survey attached

• SQL 2000 Server SQL 2000 Server • File/Application serverFile/Application server

• Main applications include SPSS, SlideWrite, DaDisp, Main applications include SPSS, SlideWrite, DaDisp, Teleform, Nutritionist ProTeleform, Nutritionist Pro

• Data is backed up to DLT on a Dell auto loading Power Data is backed up to DLT on a Dell auto loading Power Vault tape backup systemVault tape backup system

• Additionally the informatics core supports approximately Additionally the informatics core supports approximately 40 other pieces of hardware, including workstations, 40 other pieces of hardware, including workstations, scanners, network printers, etcscanners, network printers, etc


Main pointsMain points

• GCRC’s are diverse and eclecticGCRC’s are diverse and eclectic• Commonalities exist regarding areas of studyCommonalities exist regarding areas of study• Informatics cores are diverse between sitesInformatics cores are diverse between sites

• Different hardware, operating systems, software Different hardware, operating systems, software applications, emphasis, etc.applications, emphasis, etc.


Suggestions/QuestionsSuggestions/Questions

• Include other GCRC components and Cores Include other GCRC components and Cores • Possibly identify a candidate disease to begin to Possibly identify a candidate disease to begin to

see how these tools might be applied to non see how these tools might be applied to non imaging as well as imaging protocolsimaging as well as imaging protocols

• Will BIRN software tools need to be modified to Will BIRN software tools need to be modified to apply to GCRC research interests?apply to GCRC research interests?

• Science driven? Science driven? • What problems can we apply these tools to?What problems can we apply these tools to?


Suggestions/QuestionsSuggestions/Questions

•Additional FTE’s???Additional FTE’s???

Documents

6/3/2015 GCRC's and the BIRN 1 General Clinical Research Centers and the BIRN Paul Shragg, M.A. UC San Diego, GCRC