Study Coordinator Training MODULE 3: site selection

Study Coorindator Training Module 1: Introduction to Clinical Research Module 2: How to Read a Protocol Module 3: Site Selection Module 4: Study Start up Module 5: Recruitment, Informed Consent and Screening Visits Module 6: Participant Visits Module 7: Study Safety: SAEs, AEs and Conmeds Module 8: Investigational Product (IP) Module 9: Investigator Site Files and Regulatory Compliance Module 10: Monitoring Visits and Audits Module 11: Study Closeout and Archiving

Tips for the Best Learning Experience It is recommended that you have on hand the following material to enhance your learning experience: The National Statement on Ethical Conduct in Human Research (2007) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA comments These documents can be downloaded for free from the TGA websites. To ensure you have the most up-to-date version, enter the document name into your search engine. When you see this this symbol, you will be asked to pause the presentation to complete a practical activity. These activities are designed to enhance understanding and improve retention. It is highly recommended that you complete these activities.

Learning Objectives By the end of this unit, you will be able to Explain the importance of a Confidentiality Agreement (CDA) Apply the principles of confidentiality to common scenarios Explain the purpose of a Feasibility Questionnaire Complete a Feasibility Questionnaire for your site Accurately calculate potential patient population Prepare for and conduct a successful Site Selection Visit (SSV)

Site Selection Process Follow-up Site Selection Visit Feasibility Questionnaire Confidentiality Agreement (CDA) First Contact Site Selection Process

Confidentiality Agreement (CDA) The purpose of a CDA is to prevent of disclosure of a sponsor's proprietary information to someone other than an authorised individual. You must keep in mind that the CDA: Is a legal, binding document Applies to everyone employed by the institutions named in the agreement Can technically be signed by anyone at the institution BUT most institutions will request that it is signed by the CEO/Director or equivalent person. CDA is usually handled as part of the governance process. Will differ from Sponsor to Sponsor. Example CDA from Western Australia Department of Health:

Confidentiality In the course of your work you will come across confidential information on a regular basis. The basics of confidentiality are as follows: Do not share information provided by the Sponsor (eg protocol, investigational product, contact details) WITH ANYONE unless they are covered by the CDA. Even then, information should be shared on an “as needs” basis. Information available in the public domain is not considered confidential. If you are unsure, treat as confidential. Access to study related items (files, kits, IMP, etc) should be restricted to study staff. Study related items should be stored in locked rooms/cabinets. Electronic confidential information should be stored on a secure server accessible only to study staff. Google Drive is not a secure server. Sponsors/CRAs should not have access to information about another study. CRAs should not be left unattended where there is potential to access confidential information from another company.

Confidentiality The following are real-life scenarios. How would you respond? Discuss with a colleague. You are talking with a study coordinator from another site at an Investigator meeting. She asks you about how you plan to approach the complex laboratory testing required by the protocol. What do you do? She asks about recruitment on another study that is active at your site. How do you answer? Would you respond differently if you knew her site was also participating in the study? A doctor, who has a private practice near your institution, contacts your office. By searching the Clinical Trials Registry, he has discovered that your site is running a trial that would benefit one of his patients. He asks for a copy of the protocol to be sent to his office so he can pre-screen the patient. What do you do? What if he had asked for only for the inclusion/exclusion criteria? Would you respond differently if the doctor was also a consultant at your institution? A Sponsor sends your site a feasibility questionnaire. One question asks about other research being conducted at your site. The sponsor wants to know how many studies you are currently conducting, what indications they are for, how many participants you have recruited and start/stop dates for the studies. How do you answer this question, bearing in mind you want to be selected for the study? In a follow-up email, the Sponsor asks if you are participating in the STORM study run by a competing company. How do you respond?

Feasibility Questionnaire Purpose of a Site Feasibility Questionnaire (SFQ) is to find the best sites for each study. Commonly asked questions include: Number of patients at your site – both general and study-specific populations General information about competing studies Contact details for key staff at your site – investigators, coordinators, pharmacy, radiology etc HREC and Governance process and timelines The SFQ is expected to be completed within 2-5 days of receipt. Let the Sponsor know as soon as possible if this is not going to be possible and provide an alternative completion date The most important part is to accurately calculate the patient population. You will be held to this number if selected as a site so it is important to estimate accurately.

Feasibility Questionnaire WHY YOU SHOULD BE HONEST ON A FEASIBILITY QUESTIONNAIRE Even a good study will recruit poorly if it is placed at the wrong site. Exaggeration of patient numbers sets unrealistic expectations. The Sponsor will include this projected recruitment number into the CTRA. Poor recruitment decreases the site’s chance of being selected for other studies. Being too conservative can lead to your site (incorrectly) not being selected or too many sites being opened, causing competitive recruitment and shortened recruitment period. Poor recruitment is a waste of time and money for both the Sponsor and the Investigator. Once a study is initiated, there are no further payments to site until subjects are enrolled. The longer it takes to recruit patients, the higher the overhead of the study.

Feasibility Questionnaire Click on this link for a spreadsheet template HOW TO CALCULATE THE PATIENT POPULATION Best Practice Recruitment numbers from previous studies in the same or similar patient population. Keep a spreadsheet of patient recruitment for your site, making sure to include screen failures and data on patients who did not complete the study Database of potential patients that is searchable by medical condition or other parameter Dependent on patient population , the lab or pharmacy may be able to help by searching for something unique to the patient population eg HbA1C tests or dispensings of a 2nd line drug. Alternative methods Chart review Very time consuming! Unless very well staffed or very small institution, it is hard to do. Extrapolation Review subset of patients (eg all attending in a given month) and use data to extrapolate numbers Doctors estimates Method least preferred by Sponsors due to inaccuracy

Feasibility Questionnaire Complete this example feasibility questionnaire: In order to open the document, you will need an internet connection. Click on the image to open the Affinity Documents website. Select Example Feasibility Questionnaire from the list of documents.

Site Selection Visit A Site Selection Visit (SSV) is a pre-study visit performed on behalf of the Sponsor to ensure the Investigator will be able to conduct the study in compliance with the study protocol and GCP. An SSV may also be known as a Site Qualification Visit (SQV). The visit will confirm that the Investigator is appropriately qualified, has adequate resources (including potential patients, staff, equipment and facilities) and is able to provide oversight for the study. The SSV lasts for 1-4 hours during which the Clinical Research Associate (CRA) conducting the visit will meet with the Investigator for 30-60 minutes. If the Investigator is not available for the entire SSV, a study staff member must be available to facilitate the visit. Ideally, this should be the study coordinator that will be allocated the study should the site be selected.

SSV Preparation It always makes a good impression if you are prepared. PRIOR to the visit: Book appointments to tour the pharmacy and meet with the pharmacist Most requested documents are SOPs for temperature monitoring of IMP, CV (signed and dated) of lead pharmacist Book appointment to tour the laboratory and meet with the head of the lab Most requested documents are Medicare certificate, NATA accreditation certificate, lab reference ranges (signed by head of lab) and CV (signed and dated) of head of lab and IATA training certificate for person responsible for shipping biological specimens Book appointment with the PI, any Sub-I’s, study coordinators and other relevant staff Most requested documents are CV (signed and dated) and GCP certificates for all study staff and Informed Consent SOP Ask the CRA what else needs to be inspected. Make appointments as necessary. Common areas are IMP administration area, medical emergency procedure, inspection of radiology facilities and monitoring area (WiFI or computer access). Did you know you can check your lab’s NATA accreditation online?

Tips for a Successful SSV The SSV is like a job interview – the Sponsor is interviewing your site for the chance to be a part of their trial. Conduct yourself appropriately. Create a favourable impression: Have all your documentation signed and ready to hand to the CRA at the SSV. Ensure all areas to be inspected are tidy, organized and professional Dress appropriately. A professional appearance is a reflection of a professional site. Review the protocol. Highlight anything that your site will perform well. For example, 24 hour on-site lab staff will ensure PK samples are processed on time. Ensure that you have adequate patient numbers and be able to demonstrate ability to recruit strongly. Perform a quick search for eligible patients to have current data to back up your claims. Have a draft recruitment plan prior to the visit.

SSV- Follow up After the Site Selection Visit, the CRA will write a report and forward to the Sponsor for review. The Sponsor will then make a decision about the number and location of sites. It is not uncommon for the CRA to ask follow-up questions and ask for further documentation whilst compiling their report. This process takes anywhere from 1 day to 2 years! Check in with the CRA regularly. If your site is selected, you will receive a letter from the Sponsor. It is important to have this Site Selection letter before proceeding with HREC or Governance submission. If you do not receive a letter confirming selection, you may not be paid for any submission work that you perform. If your site is not selected, make sure to inform the Sponsor if you are interested in becoming a back-up site. A back-up site is a site held in reserve in case another site drops out or if recruitment is too slow.

End of Module 3: Site Selection I hope you have enjoyed this module. The next module in the study coordinator training series is: Module 4: Study Start up If you have any feedback, please let your instructor know or email the author: pm1@affinityresearch.com.au Thank you for your attention.

Study Coordinator Training MODULE 3: site selection www.affinityresearch.com.au