Clinical Trials Pharmacy Service Credentialing Program

This activity has been accredited for 33 hours of Group 1 CPD (or 33 CPD credits) suitable for inclusion in an individual pharmacist’s CPD plan which can be converted to 33 hrs of Group 2 CPD (or 66 CPD credits) upon successful completion of relevant assessment activities. 

The accreditation number is A2504CTS1

The 2016 Competency Standards addressed by this activity include:

• 1.1 Uphold professionalism in practice

• 1.2 Observe and promote ethical standards

• 1.3 Practise within applicable legal framework

• 1.5 Apply expertise in professional practice

• 2.2 Collaborate with professional colleagues

• 2.3 Communicate effectively

• 3.1 Develop a patient centred, culturally responsive approach to medication management

• 3.2 Implement the medication management strategy or plan

• 3.3 Monitor and evaluate medication management

• 3.4 Compound medicines

• 3.5 Support Quality Use of Medicines

• 4.2 Manage professional contribution

• 4.3 Show leadership in practice

On completion of the pharmacist credentialing component, participants should be able to:

1. Describe the legal and ethical considerations when conducting clinical trials in Australia
2. Describe the roles, responsibilities and essential clinical skills of the clinical trial pharmacist
3. Overview Good Clinical Practice and its importance in the context of pharmacy clinical trials
4. Define key terminologies related to clinical trials including: informed consent, research protocol, investigational new drugs and institutional review boards
5. Demonstrate ability to set up a pharmacy clinical trial in a manner that complies with accepted competency standards and clinical trial guidelines
6. Demonstrate proficiency of decision making when responding to common pharmacy clinical trial scenarios (e.g. dispensing clinical trial prescriptions, responding to temperature excursions)

Online Learning:

• Learners will be provided access to self-directed e-learning modules providing education and resources for each credentialing component

Experiential Placement:

• The pharmacist credentialing component provides an opportunity for learners to attend 1x 5-day experiential placement at Alfred Clinical Trials pharmacy
• During this placement, learners will observe and support the practice of an experienced Clinical Trials Pharmacist, allowing them to apply their new knowledge and skills to practice
• During the experiential placement, learners will have the opportunity to undergo a ClinCAT assessment and scenario-based verbal Objective Structured Clinical Examinations (OSCEs)

Assessments:

• The self-directed e-learning include a multiple choice and short answer quiz
• As mentioned above, learners will undergo a ClinCAT assessment and scenario-based verbal Objective Structured Clinical Examinations (OSCEs)

What is the cost of our program?

• Total cost of the program is $2400 (including GST) excluding pharmacist travel and accommodation costs
• Additional costs are required for Alfred Health staff travelling to external pharmacy departments for site visits during the site and trial credentialing
• Please email us at pharmhub@alfred.org.au or send an expression of interest at the link below if you would like to register