The teaching and learning in this course is facilitated by:

Core clinical trials online course: For the first week of the course students will complete an online core clinical trial topic which will consist of 6 topics addressing fundamental aspects of clinical trials. This content will cover Good Clinical Practice, good documentation practice, principles of informed consent, adverse event documentation, clinical trial regulatory environment in Australia and clinical trial designs and phases. Each of these topics will involve a lecture and an online workshop involving practical examples, videos and MyUni quizzes. Good Clinical Practice will be completed through a TransCelerate approved online GCP provider, so that students are able to acquire a certificate for their CV.

Placement: The students will be placed with a clinical trial-related organization for 2 days per week, for the duration of the semester. Potential industry partners and placements will be quite heterogenous and may include: - large commercial clinical trial organizations (e.g. CMAX clinical research), - smaller clinical trial units involved in academic or commercial trials (e.g.,SAHMRI clinical trial unit, SA Health clinical trial units specific to cancer, respiratory, cardiology or other clinical trials), - private clinical trial facilities e.g., Southern Oncology Clinical Research Unit, - Clinical Research Organizations (CRO) e.g.,Avancecro- or government or non-government ethics organizations e.g.,Bellberry

Within each of these organizations, the student placement may be within a clinical study team conducting clinical trials as a student “study assistant”, or in other roles. These other roles may include participant recruitment, quality assurance, business development, data management and others. Within each of these roles the student may be part of a team facilitating the conduct of the clinical trial or may have a specific research project which they may conduct for the organization. The placement may also be a combination of these different roles and activities. By keeping the requirement of the placement broad, we will maximise our ability to attract industry partners, as well as giving our students the best applicable clinical trial research experience.

Each student will have one or more workplace supervisor(s) to assign tasks in order to foster learning about the day-to-daywork and planning of one or more aspects/programs at the workplace. The supervisor(s) will also be involved in feedback on the case-based discussion as well as a supervisor’s report, which will contribute to the student’s overall assessment.

Case based discussion: During the 11-weekplacement the student will identify 2 case-based discussion topics which they have to address. Each case would be an issue which has arisen in the workplace which requires additional inquiry by the student and requires consideration of the applications of the principles of Good Clinical Practice, good documentation practice, ethics, or other research related to clinical trials. The student would discuss the case with their supervisor who would provide feedback to the student. In many instances, these cases will arise out of the work which the student is already doing and discussing with their supervisor, hence this should not be an additional time impost on the supervisor. The student would then present a summary of the issue, their approach, their learnings and reflection to other students at the weekly workshop, and this presentation would be assessed. They would also submit a written version of the case discussion which will also be assessed.

Completion of competencies: Each student is expected to complete a total of 4 competencies (2 core mandatory and 2 elective) for the completion of the course. Each competency will be signed off by the placement supervisor.

The core competencies are: Good Clinical Practice and Good Documentation Practice.

The elective competencies will vary depending on the organization and the role which the placement involves at each organization. Each competency should be assessed as complete if it is performed at the standard expected of a junior employee within that organization.

The following are examples of competencies which may be acquired in different clinical trial settings:

-Clinical (each of the following would be one competency to be completed): 

• Vital signs assessment
• Performing an electrocardiogram
• Venepuncture
• Hand hygiene
• Adverse event documentation
• Specific clinical assessments for different settings e.g., administration of a clinical assessment tool

-Participant consent

-Identification of participants using inclusion/exclusion criteria from clinical sources e.g.,database, electronic health record

-Competencies based on work in:

• Recruitment
• Quality assurance
• Data monitoring

The specific competencies which the student is expected to learn should be determined by the supervisor in the first 2 weeks of the placement.

Workshops: A weekly workshop would be held for up to an hour and a half. In the first few weeks, these will involve students providing brief presentation of the clinical trial organization and their roles, human and indigenous ethics, and professional workplace behaviour and teamwork. From week 4 onwards, students will present their case based presentations to other students. These case-based presentations will provide an opportunity for students to learn from other students performing different roles within varied organizations to broaden their clinical trial experience, and the application of their coursework to problem solving in clinical trials. These workshops will also encourage and assess effective oral communication skills. The workshops will also present an opportunity to identify and address any gaps in the knowledge which students have in their workplace through interactive content presentation by academics or industry guests.

Role of the academic supervisor: It is the student’s responsibility to initiate and maintain correspondence with their placement supervisor in order to get feedback on their placement. Students will be offered the opportunity to meet individually with the course coordinators throughout the semester to discuss their progress with their placement and project.

Code of practice: Students must complete a Student Learning Agreement and have it signed by the course coordinator and the placement supervisor. This form needs to be completed after consultation with the placement supervisor regarding the nature and extent of the student’s placement and a copy should be provided to the course coordinator in Week 2.

All students will be provided with a copy of the University of Adelaide Work Experience and Community Placement Guide and they are required to complete Part A of the booklet, and then ask the placement organisation to complete Parts B and D. This must be returned to the University in Week 2.

Students should be aware that the host organisations have busy working environments and that students should act at all times with respect for the normal daily activities of the host organisation. As well as a general requirement for appropriate standards of behaviour, decorum, and dress, there are a number of specific protocols that must be observed.

Confidentiality: All students should be aware that any organisation may be operating in a sensitive environment. It is essential that students adhere to a code of absolute confidentiality and discretion. All information gained through access to the papers and other materials of host organisations should be regarded as confidential unless otherwise notified. The long-term success of the Program depends on students acting in accordance with this understanding. Confidentiality also extends to the participants involved in the clinical trials as per the principles of Good Clinical Practice.

Status on placement: Each student should accept the same disciplines and constraints to which salaried staff are committed. It is important that students should not allow anyone to believe that they are members of staff. During their period of internship, students at all times remain enrolled members of the University of Adelaide and are expected to abide by the usual policies and by-laws of the University.

Correspondence: While it may be appropriate for some correspondence in connection with your role to come from the office of the host organisation, nothing should be sent under the letterhead of an organisation without prior permission.

Expenses: Any travelling costs to the placement site, or other incidental costs incurred by students as part of the placement will remain the responsibility of the student. Neither the University nor the participating organisations have any funds to meet such expenditure.  Any other arrangements must be directly negotiated and agreed upon between student and supervisor.

Police check: The placement organisation(s) may require that the student acquires a National Police Certificate prior to commencing the work placement. In that case, it is the student's responsibility to apply for the police clearance and present the certificate to his/her workplace organisation. In order to reduce delays, it is advisable that students obtain a Police Certificate in advance, if there is any doubt about the need for one. If the organisation requires such police check, that will be recorded in the Placement Agreement.  Australian citizens and permanent residents can apply for a police check at either: National Crime Check: https://www.nationalcrimecheck.com.au/police_check_south_australia_sa Or through SA Police at https://www.police.sa.gov.au/services-and-events/apply-for-a-police-record-check International students can apply for a certificate through: https://www.afp.gov.au/what-we-do/services/criminal-records/national-police-checks#process

Online quizzes (20%): There will be online quizzes as part of the initial online core course which will be formative but some of the quizzes related to the course content will be summative and account for 20% of the course assessment.

Workshop class participation (10%): Students will be expected to actively engage in the workshops, to ask questions, to perform group presentations, where relevant, and to participant in online or face to face lectures discussions. This assessment will be performed by the workshop supervisor and will make up 10% of the overall marks.

Case based learning assessment (30% in total): During the course of the placement the student will identify 2 case based discussion topics which they have to address. These topics would typically be an issue which has arisen in the workplace which requires additional inquiry by the student and requires consideration of the applications of the principles of Good Clinical Practice, good documentation practice, ethics, or other principles related to clinical trials.

Typical examples include consideration of how an adverse event with a complicated course should be documented, considerations of consent for a vulnerable individual or from a poor educational background, ethical considerations around updating participants when new information becomes available, issues around documentation in an electronic case report form.

This assessment will consist of two parts. The student will present a summary of the issue, their approach, their learnings and reflection toother students at the weekly workshop, and this presentation would be assessed by the workshop supervisor and will constitute 7.5% of the overall marks for each case. They will also submit this information in writing and this will also constitute 7.5% of the overall marks for each case. As there are two cases, the overall marks for this activity would be 30%

Workplace supervisor feedback (15%): Assessment by the respective workplace supervisor carries 15% marks for the course. The workplace supervisors are requested to make this assessment using the Supervisor Report Template.

Poster presentation of learning activities (15%): Students will be asked to present a poster summarising their work integrated learning experience. For students who have been given a specific project as part of their role, they would present the project findings. Other students who have been embedded as part of a team conducting clinical trials they would summarise the aspect of the trial(s) which they have been involved with.