Hospital Raja Perempuan Zainab II

Hospital Kota Bharu was established in the 1920s. In remembrance of the late Sultanah Kelantan, this tertiary care facility name was changed to Hospital Raja Perempuan Zainab II (HRPZII) and the ceremony was officiated by Kebawah Duli Yang Maha Mulia Al-Sultan Kelantan Tuanku Ismail Petra Ibni Almarhum Sultan Yahya Petra on 5 September 2005.  HRPZII is the main referral centre for the entire state of Kelantan and Northern District of  Terengganu. The undergraduate medical students from University Sains Malaysia (USM) and Post Graduate Distance Learning Program (PJJ) doctors use HRPZII for their practical training, as well as trainees preparing for examination conducted by Universiti Kebangsaan Malaysia (UKM), USM and professional bodies overseas. Basic and post basic training for paramedical personnel and are conducted as in-service training for all categories of staff. In addition, HRPZII was recently appointed as a Regional Hub for Telemedicine, Regional Referral Centre for Psychiatry service and Regional Clinical Research Centre (CRC).

SPECIALTY

  • Accident & emergency
  • Anesthesiology
  • Dermatology
  • Forensic
  • Medical
  • Nephrology
  • Obstetrics & Gynaecology (O&G)
  • Ophthalmology
  • Oral surgery
  • Orthopaedic
  • Otorhinolaryngology
  • Pathology
  • Pediatric
  • Psychiatry
  • Radiology
  • Rehabilitation
  • Surgical

 

Evolution of CRC Kelantan

2002

  • CRC Hospital Kota Bharu created and operated as one of the quality activities at hospital level.

2007

  • Renamed to CRC Kelantan and has expanded its scope of services to state level.
  • Operates as an independent unit and is listed among other units and departments at HRPZII.

2013

  • CRM SC joins in as part of CRC Kelantan.
  • Officially selected as 1 out of 11 IQVIA (previously known as Quintiles) Prime Sites.

2015

  • CRC Kelantan office relocated to hospital staff quarters.
  • Comprises of 2 treatment rooms/clinics and research room used to conduct Industry Sponsored Research (ISR) and Investigator Initiated Research (IIR).

2017

  • Addition of CRC office space, SIV/monitoring room, Head of Unit room, staffroom,   record room and tutorial room.

2018

  • Officially selected as PARAXEL Preferred Site.

Total  staff : 19
Specialist : 2
Medical officer : 2
Pharmacist : 1
Research officer : 1
Nurse : 2
Administrative officer : 1
Contract Officer : 1
CRM Study Coordinator : 7
Freelance Study Coordinator : 2

 

Services

Consultation

  • NMRR online registration
  • Protocol & proposal development
  • Literature search / review
  • Review of Research Protocol for IIR
  • Statistical consultation
  • Manuscript and abstract write up
  • Assist in submission of research papers
  • Assist in grant application

Training

  • Good Clinical Practice (GCP)
  • Introduction to Clinical Research (ICR) Workshop
  • Statistical Analysis Workshop
  • Study Coordinator Workshop
  • Research Methodology Workshop
  • Scientific Writing Workshop
  • East Coast Research Camp
  • Other research related courses

 

Facilities

START UP TIMELINES, METRICS, QUALITY AND ACHIEVEMENTS

Average Days

Start-Up timelines: <75 days
Quality: 94.8% (IQVIA Spotfire 19thOct 2018)
SIV to FPFV: <60 Days
Contract Executed timelines: 30 days

 

Read more contents from CRM Bulletin Issue 16. Download here!

Standard Operating Procedures (SOP)

  • Availability of CRM SOPs at site enable site to use it as reference/guide for the conduct of clinical trial.
  • Each CRM SCs are certified, and they can train other hospital site staff on the proper conduct of clinical trial.

 

IQVIA Prime Site

  • Hospital Raja Perempuan Zainab II was selected as one of the 11 Prime Site in Malaysia in 2013.
  • This partnership enables to benchmark Malaysia with other global countries for these contributing factors; increase number of clinical trial, improve start up timeline, High quality and meet/exceed patient recruitment targets.

 

PAREXEL Preferred Site

  • Officially selected as PAREXEL Preferred Site on 21stNov 2018.
  • Objective: to outline the preferred site strategy, better understand site’s areas of therapeutic interest, capabilities, capacity and infrastructure and explore whether there are areas of mutual interest.
  • Ultimately, if both parties felt there was a desire for, and benefit in, a more strategic collaboration, PAREXEL would work with site’s leadership team to increase the flow of clinical trial opportunities to site, identity a relationship manager within PAREXEL to oversee the collaboration and agree how best to optimise communication and processes between the two parties.

HRPZII awarded for Highest Number of Newly Approved Endocrinology Clinical Trials in Year 2016.

 

CRM has successfully achieved the accreditation for ISO 9001: 2015.