Clinical research UnitThink big, start small, scale fast

Joana ClaverolClinical Research Unit Manager

Highlights

ACTIVITY

Outpatient visits: 234.950Emergencies: 115.413Surgical operations: 14.100Deliveries: 3.245Inpatient admissions 25.374

RESOURCES

Staff: 1.642Beds: 328Outpatient visit boxes: 134OR: 13

Leading specialties

Heart Neurology Oncohaematology

Orthopaedic and

traumatology

surgery

Fetal medicine -

NeonatologyRare diseases

Patient/family centred hospital

Patientadvocacy in

research

Health 2.0

PatientExperience Hospital Amic

Healthcare

Research

Clinical Trials

Innovation

Technology

The pediatric Clinical Trial’s UnitDesign process

• HR: Roles and responsibilities

• Training

• Facilities

• Marketing

• The expert patient

• Networking

• Goal: to build up a pediatric clinicalresearch unit within a Pediatric hospital

Where to start?

Listen inside

to contrast

Observe Out

The big players

• Quality SOPs• Research

Training

HHRR TRAINING FACILITIES MARKETING

• Study Coordinator

• Research Nurse

• CRU • Communicaction• Advertisement

Clinical Research Coordinator I , II, IIIResearch Nurse I, II, III

Main Role

• Coordinate the Clinical trial at sitelevel

• Regulatory activities

• Recruitment (CI) and retention

• Communication with allstackholders

• Data management

• Training of researchers

• Clinical activities (studyporcedures)

Competencies

• Responsibility

• Communication

• Organization

• Flexibility

• Autonomy

• Appreciation of diversity

• Leadership and decision making

• Security

• Ethical principles

• Advanced scientific terminology

• Handling of lab an otherequipment

Background

• Scientific background

• Nursing

• Annual training plan

Job DescriptionHHRR

Research Nurse I, II, III

• IACRN : http://iacrn.org/

• IACRN is a professional nursing organization. Its purpose is to define, validate and advance clinical research nursing as a specialty practice and to support the professional development of registered nurses who directly or indirectly impact the care of clinical research participants across all clinical specialties.

HHRR

Quality - SOPsResearch Training

• Welcome package

• Orientation Research Training: internal, mandatoryfor all the personnel that works in clinical research (includes GCP, Ethical Priniciples, Informed Consent, Saftey Reporting…)

• Core Clinical Research Training : external, developedwith Universitat de Barcelona. Focused on the rol of the study coordinator at site level. To be done by allresearch nurses

TRAINING

•Quality assurance: Investigators and staff trained on CRU SOPs•SOP 0.1: Preparation, approval, distribution and review of Standard Operating Procedures for Clinical Trials Unit•SOP 0.2: Storage and retention of documents of clinical trials•SOP 1.1: Description of the Clinical Trials Unit•SOP 1.2 Equipment of Clinical Trials Unit, maintenance and periodic validation of the material and devices•SOP 2.1 Human Resources of the Clinical Trials Unit•SOP 3.1: Procedure for collection and reporting of adverse events•SOP 3.2: Procedures for medical emergency•SOP 3.3: Evacuation of the Clinical Trials Unit in non medical emergencies•SOP 4.1 Handling, storage and shipment of biological samples•SOP 4.2:Management of study medication in the Clinical Trial’s Unit•SOP 5.1: Evaluation and set up of a clinical trial•SOP 5.2: CTA management and Budget •SOP 5.3 Start up visit and recruitment•SOP 5.4 : CRF data entry•SOP 5.5: Monitoring, audits and inspections•Sop 5.6: study close out•SOP 6.1: Collection and Signature of the Informed Consent•SOP 7.1 : Protocol deviations and scientific misconduct

TRAINING

Exam rooms with calibrated equipments , own pharmacy, lab to processstudy samples, monitoring area, administrative area with all ISF

FACILITIES

The result: Clinical Research Unit

CRU

Patients

sponsor

CRO

Monitor

Otherservices

Pharmacy

Investigator

CRU Services:single point of

contact

126 Clinical Trials(116 pediatric)

57 ObservationalStudies

12 Clinicalresearchprojects

5 Innovation Projects

Activity : 200 active projects

21 pediatric areas80% Commercial CT

0 5 10 15 20 25 30 35 40

Estudios Clínicos Activos

Laboratori HSJD

Alergia e immunología clínica

Anestesia

Área del corazón

Cirugía

Dermatología

Endocrinología

Gastroenterología, hepatología y nutrición

Hematologia clínica

Nefrología

Neonatologia

Neurología

Oftalmología

Oncología

Ortopedia y traumatologia

Pediatría

Psiquiatría / Psicología

Rehabilitación y medicina física

Ginecología y Obstetrícia

Impact of the pediatric regulation in Spain

.

1319

33 34 36

45

58

72

94

103

112

2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

The CRU has catalizedthe growth in recent

years

High complexity clinical trials20% Phase I

I20%

II32%

III46%

IV2%

Hematology13%

Neurology7%

Oncology33%Palliatives

7%

Infectious d.13%

Rheumatology27%

Early phase trials

• The expert patient:

Joana Claverol

Enero 2016

• The vocie of patients:

www.kidsbarcelona.org

Patientadvocacy in

research

INTERNATIONAL

NATIONAL

LOCAL

NETWORKING AND ACCREDITATIONS

EPCTRI

Phase 1 UnitFarmaindustria Guide