And Clinical Knowledge In Traumatic Brain Injury Clinical Protocol

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Transforming Research and Clinical Knowledge in Traumatic Brain InjuryClinical ProtocolMarch 3, 2016Version 12TRACK‐TBI Clinical ProtocolPage 1

Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK‐TBI)Clinical Protocol December 2014Table of Contents1. Leadership, Sites and Contacts . 41.1. Leadership . 41.2. TRACK‐TBI Principal Investigators . 41.3. TRACK‐TBI Steering Committee Members. 51.4. Sites and Contacts . 62. Study Overview . 173. Structure and Governance . 183.1. Steering Committee. 183.2. Executive Committee. 183.3. Innovative Distributed Cores Model . 193.4. Public‐Private Partnership Resources . 203.5. Scientific Advisory Board . 203.6. Community Advisory Board . 204. Objectives and Specific Aims. 214.1. Specific Aim 1 . 214.2. Specific Aim 2 . 214.3. Specific Aim 3 . 254.4. Specific Aim 4 . 275. Study Design and Sample Size . 305.1. Subject Groups . 305.2. Assessment Cohorts . 305.3. Patient Cohort Selection for MRI . 315.4. Clinical Protocol Grid . 315.5. Milestone Plan . 326. Subject Eligibility . 336.1. Inclusion/Exclusion Criteria . 347. Subject Procedures by Core . 357.1. Clinical. 357.2. Biospecimens . 357.3. Neuroimaging. 357.4. Outcomes . 358. Subject Recruitment and Screening . 398.1. Subject Identification . 398.2. Screening Process . 398.3. Participation Requirements . 398.4. Subject Compensation . 409. Informed Consent . 419.1. Informed Consent Personnel . 419.2. Location and Privacy . 419.3. Competency Screening . 419.4. Language and Literacy . 419.5. Need for Reconsent . 419.6. Storage of Consent Documents . 429.7. Waiver of Consent .42TRACK‐TBI Clinical ProtocolPage 2

10. Subject Risks and Benefits . 4310.1. Foreseeable Risks by Core . 4310.2. Protections Against Subject Risks . 4410.3. Certificate of Confidentiality . 4510.4. Potential Benefits of Proposed Research . 4611. Subject Compliance and Retention . 4712. Data Management and Compliance . 4812.1. Clinical . 4812.2. Biospecimens . 5012.3. Neuroimaging. 5113. Adverse Events . 5214. Data Sharing . 5314.1. Internal Data Sharing . 5314.2. External Data Sharing . 5315. Clinical Protocol Maintenance . 5415.1. Protocol Modifications . 5415.2. Protocol Deviations . 5416. Reference List . 55Appendix 1: Pediatric ProtocolAppendix 2: Screening and Consent Forms2.1: Screening Log2.2: Informed Consent FormAppendix 3: Clinical Case Report FormsAppendix 4: Biospecimens Full ProtocolAppendix 5: Neuroimaging Full ProtocolAppendix 6: Outcomes Full Protocol6.1: Adult Outcome Measures6.2: Pediatric Outcome MeasuresAppendix 7: Policy and Procedure for Revisions to the TRACK‐TBI Manual of Operating ProceduresTRACK‐TBI Clinical ProtocolPage 3

1.LEADERSHIP, SITES AND CONTACTS1.1 LEADERSHIPTRACK‐TBI is a large and complex project. Its institutional and public‐private partnership is comprised of 11clinical sites, 7 Cores, for a total of nearly 50 collaborating institutions, corporations, and philanthropy. Frominception, we recognized that a clear and comprehensive governance and leadership plan would be essentialto the success of the scientific and administrative aspects of the project. The multi‐PI plan presented hereemphasizes excellence, inclusiveness, collaboration, and efficiency.Governance will implemented by the PIs, advised by a Steering Committee, to promulgate critical policy andstrategic decisions, executed by an Executive Committee, through the work of a model of distributed Cores ofscientific and administrative expertise (Administrative, Clinical, Biospecimens, Informatics, Neuroimaging,Outcomes, Biostatistics/Comparative Effectiveness Research). Each of the 7 PIs, and a specially appointedInformatics expert, serve as the Core Leaders, sometimes in conjunction with a Core Co‐Leader who hascomplementary expertise. At each of the 11 Study Sites, we have appointed a Study Site Leader, who workswith 1 or more Co‐Investigators at that site, selected for their mix of strengths across the Cores. TheLeadership will also benefit from the input of a Scientific Advisory Board and a Community Advisory Board, asto strategic research participation and planning, and dissemination of TRACK‐ TBI scientific findings.1.2TRACK‐TBI PRINCIPAL INVESTIGATORS (EXECUTIVE COMMITTEE)NameRoleInstitutionGeoffrey Manley, MD, PhDContact PI Administrative Core Leader Study Site LeaderUniversity of California,San FranciscoClaudia Robertson, MDPI Clinical Core Leader Study Site LeaderBaylor College of MedicineDavid Okonkwo, MD, PhDPI Clinical Core Leader Study Site LeaderUniversity of PittsburghRamon Diaz‐Arrastia, MDPI Biospecimens Core LeaderCenter for Neuroscience andRegenerative Medicine, USUHSNancy Temkin, PhDPI Biostatistical/CER Core LeaderUniversity of WashingtonPratik Mukherjee, MD, PhDPI Neuroimaging Core LeaderUniversity of California,San FranciscoJoseph Giacino, PhDPI Outcomes Core LeaderSpaulding Rehab HospitalHarvard Medical SchoolRotating SteeringCommittee MemberTRACK‐TBI Clinical ProtocolPage 4

1.3TRACK‐TBI STEERING COMMITTEE MEMBERSNameRoleInstitutionPrincipal Investigators (7)See aboveSee aboveAnn‐Christine Duhaime, MD Clinical Core Co‐Leader (Pediatrics) Site Leader Harvard Medical School‐MGHDana Goldman, PhDBiostatistical/CER Core Co‐LeaderUniv. Southern CaliforniaArthur Toga, PhDInformatics Core LeaderUniv. Calif. Los AngelesKevin Smith, MSISInformatics Core Co‐LeaderUniv. MichiganOpeolu Adeoye, MDStudy Site LeaderUniv. CincinnatiNeeraj Badjatia, MDStudy Site LeaderUniv. MarylandRandall Chesnut, MDStudy Site LeaderUniv. WashingtonGillian Hotz, PhDStudy Site LeaderUniv. MiamiChristopher Madden, MDStudy Site LeaderUniv. Texas South WesternRandall Merchant, PhDStudy Site LeaderVirginia Commonwealth Univ.Mateo Ziu, MDStudy Site LeaderSeton Brain & Spine InstituteAustinAndrew IR Maas, MDMember PI of CENTER‐TBI/InTBIRAntwerp University Hospital,Edegem, BelgiumDavid Menon, PhDMember Co‐PI of CENTER‐TBI/InTBIRUniversity of Cambridge,Cambridge, UKIsabelle Gagnon, MSc PhDMember PI Canadian Institutes of HealthResearch (CIHR) InTBIR Team GrantMcGill Univ. Health Centre,Montreal, CanadaTRACK‐TBI Clinical ProtocolPage 5

1.4SITES AND CONTACTSUniversity of California, San Francisco (UCSF)San Francisco General Hospital (SFGH)Brain and Spinal Injury Center (BASIC)1001 Potrero Avenue, Building 1, Room 101, Box 0899San Francisco, CA 94110RoleNamePhoneEmailPrincipal InvestigatorGeoffrey Manley, MD, InvestigatorPratik Mukherjee, MD, nvestigatorEsther Yuh, MD, PhD415‐206‐5871esther.yuh@ucsf.eduExecutive DirectorMary Vassar, RN, al Trial ManagerGabriela search CoordinatorJohn Yue, h CoordinatorCaitlin RACK‐TBI Clinical ProtocolPage 6

University of Washington (UW)Harborview Medical Center325 9th Avenue, Box 359924Seattle, WA 98104RoleNamePhoneEmailPrincipal InvestigatorNancy Temkin, ureyya Dikmen, andall Chesnut, MD206‐744‐9322chesnutr@uw.eduPsychometristKim rch ScientistJoan Machamer206‐616‐0340Machamer@uw.eduResearch CoordinatorSara Wellnitz, orLaurie Peabody206‐897‐4302lpeabody@uw.eduTRACK‐TBI Clinical ProtocolPage 7

Massachusetts General Hospital (MGH)MGH, Wang Ambulatory Care Center, Suite 331Fruit StreetBoston, MA 02114RoleNamePhoneEmailPrincipal InvestigatorAnn‐Christine Duhaime, estigatorJonathan Rosand, MDResearch CoordinatorScott HaireAdmin ContactBeth Costine, tners.orgbcostine@mgh.harvard.eduSpaulding Rehabilitation Hospital (SRH)300 First Avenue, Room 3227Charlestown, MA 02129RoleNamePhoneEmailPrincipal InvestigatorJoseph Giacino, PhD617‐952‐5254jgiacino@partners.orgPrincipal InvestigatorRoss Zafonte, DO617‐952‐5227rzafonte@partners.orgResearch CoordinatorYelena Guller, PhD617‐952‐6308yguller@partners.orgResearch CoordinatorSabrina Taylor, PhD617‐952‐6392srtaylor@partners.orgResearch AssociateBrendan Kelley, BS617‐952‐6306brkelley@partners.orgResearch AssociateJamie Kaminski, BI Clinical ProtocolPage 8

University of Pittsburgh Medical Center (UPMC)Brain Trauma Research CenterUPMC Presbyterian, Suite B‐400200 Lothrop StreetPittsburgh, PA 15213RoleNamePhoneEmailPrincipal InvestigatorDavid Okonkwo, MD, atorAva Puccio, RN, PhD412‐648‐9246puccioam@upmc.eduResearch CoordinatorPatty Barcic, RN, BSN412‐648‐9664barcicp@upmc.eduOutcomes CoordinatorMaureen McAniff, MS412‐624‐5270mcaniffme@upmc.eduOutcomes CoordinatorThomas HahnerRegulatory CoordinatorJulia Billigen, BS, c.eduTRACK‐TBI Clinical ProtocolPage 9

University of Cincinnati (UC)Department of Emergency Medicine231 Albert Sabin Way, PO Box 670769Cincinnati, OH 45267RoleNamePhoneEmailPrincipal InvestigatorOpeolu Adeoye, igatorArthur Pancioli, MD513‐ ason McMullan, tigatorChris Lindsell, stigatorNorberto Andaluz, igatorJed Hartings, PhD513‐558‐3567hartinja@ucmail.uc.eduResearch CoordinatorSara Keegan, Med513‐558‐8450starksk@ucmail.uc.eduResearch CoordinatorPam Schmit RN, BSN513‐558‐6142schmitpt@ucmail.uc.eduLab ManagerMatthew I. Sperling513‐558‐8992sperlim@ucmail.uc.eduAdmin ContactDaniele K‐TBI Clinical ProtocolPage 10

Baylor College of Medicine (BCM)Department of Neurosurgery6501 Fannin Street, Suite NC100Houston, TX 77030RoleNamePhoneEmailPrincipal InvestigatorClaudia Robertson, rHarvey Levin, atorPaulina Sergot, MD713‐879‐2626sergot@gmail.comResearch CoordinatorSanthosh ch CoordinatorLuis Gonzalez, gCo‐InvestigatorAngelle Sander, rMark Sherer, Co‐InvestigatorShankar Gopinath, MD713‐798‐4696shankarg@bcm.eduTRACK‐TBI Clinical ProtocolPage 11

University of Miami (UM)Department of Neurosurgery1095 NW 14th TerraceMiami, FL 33136RoleNamePhoneEmailPrincipal InvestigatorGillian Hotz, gatorM. Ross Bullock, MD, PhD305‐243‐ CoordinatorVianca Cabrera, RN305‐585‐ Base CoordinatorCarlos Bidot, CoordinatorLester Polo, MDTRACK‐TBI Clinical ProtocolPage 12

Seton Brain and Spine Institute a Member of SHF / University of Texas at Austin1400 N IH 35, Suite 300Austin, TX 78701RoleNamePhoneEmailPrincipal InvestigatorMateo Ziu, avid Schnyer, PhD512‐475‐8499schnyer@utexas.eduResearch CoordinatorKrishna Saini512‐324‐8300kmSaini@seton.orgVolunteer ResearchAssistantDiana Dominguez512‐324‐8300Study CoordinatorBridget Byrd, MA336‐244‐7728bridgetbyrd@utexas.eduStudy CoordinatorStephanie Sherman, MA602‐410‐0234ssherman@utexas.eduStudy CoordinatorNicholas R. Griffin810‐623‐7969ngriffin@utexas.eduStudy CoordinatorMolly F. ominguez@seton.orgTRACK‐TBI Clinical ProtocolPage 13

Virginia Commonwealth University (VCU)Department of Anatomy and Neurobiology1101 East Marshall Street, Room 12‐048Richmond, VA 23298RoleNamePhoneEmailPrincipal InvestigatorRandall Merchant, PhD, Co‐InvestigatorAbigail Vo, vestigatorBruce Mathern, InvestigatorVenkata R. Feeser, y Mathern, RN, ann Polo‐Reasor, Tanya Graf, BSc, rTRACK‐TBI Clinical ProtocolPage 14

University of Texas Southwestern5161 Harry Hines BoulevardDallas, TX 75390RoleNamePhonePrincipal InvestigatorChristopher Madden, MD214‐648‐7905Co‐InvestigatorHunt Batjer, MD214‐648‐9320Co‐InvestigatorKan Ding MD214‐648‐2315Co‐InvestigatorStephen Figueroa MD214‐648‐8513Research CoordinatorSusie Madison, RN, BSN214‐648‐2965Research CoordinatorCaryn Harper, MS, CCRC214‐648‐7613Research CoordinatorVictoria Warren RNResearch CoordinatorEzequiel CambranisResearch CoordinatorVin Shen outhwestern.eduTRACK‐TBI Clinical ProtocolPage 15

University of Maryland110 S. Paca Street, Room 4‐112Baltimore, MD 21201RoleNamePhoneEmailPrincipal InvestigatorNeeraj Badjatia, InvestigatorDeborah Stein, ao Gullapalli, PhD410‐328‐2099RPG@umm.eduResearch CoordinatorNkenna Ajagba, MS, CCRP410‐328‐8426najagba@stapa.umm.eduResearch CoordinatorIfeatu RACK‐TBI Clinical ProtocolPage 16

2.STUDY OVERVIEWEffective treatment of traumatic brain injury (TBI) remains one of the greatest unmet needs in public health.Each year in the United States, at least 1.7 million people suffer TBI; it is a contributing factor in a third of allinjury‐related US deaths. An estimated 3.2 to 5.3 million people live with the long‐term physical, cognitive, andpsychological health disabilities of TBI, with annual direct and indirect costs estimated at over 60 billion.1Recent efforts have increased our understanding of the pathophysiology of TBI; however, these advances havefailed to translate into a single successful clinical trial or treatment.2 These failures are largely attributable tothe fact that TBI classification approaches are blunt and have not changed in more than 3 decades. TBI patientsare divided into the crude categories of mild, moderate, and severe, using the Glasgow Coma Scale (GCS)3,outcomes are measured using the equally crude Glasgow Outcome Scale‐Extended (GOSE).4 These symptoms‐based categories do not permit mechanistic targeting for clinical trials. Clinical research has also beenunderpowered, hampered by lack of data standardization, and with limited multidisciplinary collaboration.Workshops coordinated by the National Institute of Neurological Disorders and Stroke (NINDS), Department ofDefense (DOD), and the National Institute on Disability and Rehabilitation Research (NIDRR) since 2007identified the urgent need for improved TBI classification using more accurate diagnostic and outcome tools(beyond the GCS and GOSE), along with a standardized approach to data collection. A multidisciplinary effortwas launched to develop TBI Common Data Elements (TBI‐CDEs). Domains included clinical data, imaging,biospecimens, and outcomes.5‐8In 2009, the NINDS‐funded, multicenter Transforming Research and Clinical Knowledge in Traumatic BrainInjury Pilot study (TRACK‐TBI Pilot ‐ PI, Manley) implemented and helped to refine the TBI‐CDEs, and created aprototype of the TBI Information Commons proposed here. This effort validated the feasibility of the TBI‐CDEsand collected detailed clinical data on 650 subjects across the injury spectrum, along with CT/MRI imaging,blood biospecimens, and detailed outcomes. It also established an infrastructure of integrated databases,imaging repositories, biosample repositories, and multicenter expertise. The TRACK‐TBI Pilot dataset is the firstto populate the Federal Interagency Traumatic Brain Injury Research (FITBIR) repository. Among the earlyfindings of TRACK‐TBI Pilot data: Co‐Investigator (Co‐I), Yuh et al9 identified early MRI abnormalities in 30% ofsubjects with mild TBI and a normal CT scan. These structural MRI abnormalities, in the first‐ever standardizedreporting of imaging features employing TBI‐CDEs, were predictive of unfavorable outcome at 3 months. Thiswork represents a significant step toward improved stratification of heterogeneous patient subgroups withinthe traditional ”mild TBI/Concussion” population. Additionally, we validated a blood‐based glial proteomicbiomarker that reliably detects the presence and severity of brain injury seen on CT scan.10 Using TBI‐CDEoutcome measures examining multiple domains revealed that subjects with unfavorable outcomes could beseparated into groups that screened positive for PTSD versus those with cognitive disability. While thisimproves precision of outcome assessment beyond GOSE, gaps in the TBI‐CDE outcome battery were identifiedwith respect to more severely injured patients, leading us to propose the flexible battery in this application.TRACK‐TBI Pilot data also permitted comparison of emergency department disposition decisions in mild TBIpatients. Co‐I Adeoye et al11 found that although hospital admission usually resulted after a finding of CTabnormalities, no difference in 6‐month outcome was observed regardless of whether the patient wasadmitted to hospital. Site‐specific factors also influenced disposition, highlighting the opportunity to examinethe variability in TBI clinical practice that influences outcome and costs.These results demonstrate the significance of a fully integrated TBI Information Commons that will: Improve TBI classification/taxonomy for targeted clinical treatment trials. Improve TBI outcome assessments, such that the size and costs of clinical trials can be reduced. Identify the health and economic impact of mild TBI patient disposition. Create a legacy database with analytic tools and resources to support TBI research.TRACK‐TBI Clinical ProtocolPage 17

3.STRUCTURE AND GOVERNANCEThe TRACK‐TBI team, in collaboration with expert public‐private partners, in a Team Science approach, is nowprepared to enroll 3000 subjects across 11 sites. Shattering the silos that traditionally separate research andclinical practices, our team includes acute‐care clinicians, neuroscientists, rehabilitation specialists, healtheconomists, and informaticists. The effort and resources of these highly qualified investigators, combined withthose of our government and industry collaborators, have created a uniquely synergistic public‐privatepartnership. The TBI Information Commons will create a high quality, widely accessible, and fully integratedTBI‐CDE dataset compatible with FITBIR and InTBIR. Collaboration within InTBIR will provide opportunities tostrengthen research approaches, and importantly, provide a global platform to connect TBI’s best scientists.The expected outcome is an international resource, statistically powered to identify new diagnostic andprognostic markers and refine outcome assessments, which will lead to successful clinical treatment trials.TRACK‐TBI’s multiple‐PI governance champions inclusiveness, collaboration, excellence, and efficiency. The PIswill share strategic planning, management, and oversight, advised by a Steering Committee, with day‐to‐dayfunctions managed by the Contact PI and an Executive Committee. An innovative, distributed core modelempowers our researchers to generate and execute initiatives. A nimble administration will assurecoordination, oversee fiscal matters, and maximize synergies through public‐private partnerships.3.1 STEERING COMMITTEEThe Contact PI will serve as first Chair of the Steering Committee (chair will thereafter rotate) and will be theNIH’s primary point of contact for the project. The PIs bear ultimate responsibility for the project, workingcollaboratively with and advised by, a Steering Committee composed of the PIs (who also lead our Cores inmost cases, described below), Core Leaders, 11 Study Site Leaders, and 3 international members. The SteeringCommittee is charged with strategic planning for research, and overseeing site operations and personnel. TheSteering Committee will make policy decisions related to key operations. The Steering Committee’s Data UseCommittee will serve as arbiter for the use of TRACK‐TBI’s data and biospecimens, according to the Data UsePolicy and IP Agreements conforming to FITBIR policies. As well, it will synthesize contributions of the Scientificand Community Advisory Boards to strategic research participation and planning. The Steering Committee willmeet via weekly teleconferences, as well as at periodic national/international meetings.3.2 EXECUTIVE COMMITTEE (EC)The EC, composed of the PIs, with a rotating member of the Steering Committee (initial member Dr. Pancioli),will have oversight of day‐to‐day TRACK‐TBI operations. The EC will be led by the Contact PI and supported bythe Administrative Core. The Contact PI will coordinate communication among PIs, including establishingmeeting schedules and agendas. The EC will make and execute final decisions as to research priorities,TRACK‐TBI Clinical ProtocolPage 18

supervise execution of studies, identify external collaborative private and public partners, ensure sound fiscalmanagement, and review financial resource allocation. It will monitor data quality and progress towardcompletion of the Specific Aims through its Data Acquisition and Quality Committee (DAQC). The EC will alsoparticipate in InTBIR’s International Scientific Advisory Committee (ISAC). Upon notification of award, the ECwill meet in‐person, followed by weekly teleconferences during which PIs will provide updates on progresstoward launch. Post‐launch, the EC will monitor Core functions with ongoing review of enrollment targets andcompliance with all clinical, data management, and regulatory/ethical protocols. Should key personnel need tobe replaced, the EC will make recommendations to the Contact PI, who will immediately alert the NIH.3.3 INNOVATIVE DISTRIBUTED CORES MODELAdministrative Core (AC). Dr. Manley and his administrative staff will have overall scientific and financialresponsibility. The AC will oversee subcontracts, prepare/monitor budgets, report to NIH Program staffregarding timeline and milestone achievement, submit progress reports, and plan/facilitate meetings andteleconferences, including distributing and archiving agendas and minutes.Clinical Core (CC). Drs. Robertson and Okonkwo will lead the CC, responsible for direct oversight of the clinicalresearch sites, reporting to the EC. The CC will develop the recruitment plan and organize training meetings aswell as approve the design of electronic Case Report Forms (eCRFs) and the Manual of Operations andProcedures (MOP). It will approve regulatory documents, track enrollment, and organize the collection ofclinical and biomarker data. Detailed CRFs can

University of Washington (UW) Harborview Medical Center 325 9th Avenue, Box 359924 Seattle, WA 98104 Role Name Phone Email Principal Investigator Nancy Temkin, PhD 206‐744‐9315 Co‐Investigator Sureyya Dikmen, PhD 206‐685‐7529

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