Recruitment Training Presentation.pptx

Recruitment Training Presentation Recruitment Team Breakdown The Recruitment team is made up of many different teams, all of which work intersectionally to make sure that that patients are getting enrolled into the proper studies. • Marketing/Recruitment Team • Call Center Team • Pre-screenin...

Recruitment Training Presentation Recruitment Team Breakdown The Recruitment team is made up of many different teams, all of which work intersectionally to make sure that that patients are getting enrolled into the proper studies. • Marketing/Recruitment Team • Call Center Team • Pre-screening Team • Patient Support Team Recruitment Team - Work Flow Marketing/Recruitment Team Marketing creates and executes marketing campaigns to attract potential participants for clinical trials. This affects the awareness and interest in clinical trials, driving inquiries to the company. Recruitment concurrently is working with their mobile clinic and reviewing previous subjects at all sites to find possible patients for upcoming studies. Call Center Team The call center team handles incoming inquiries, provides initial information about clinical trials, and screens potential participants based on basic criteria. This allows them to filter interested individuals, ensuring only qualified candidates move forward, and directs them to the next phase—pre-screening. Pre-screening Team The Pre-screen team conducts detailed screenings of potential participants, verifying eligibility criteria, collecting necessary information, and scheduling screens if needed. This determines which candidates meet the protocol’s specific criteria, preparing them for the next steps– official screening visit and ICF signed, and ensuring efficiency in the recruitment process. Patient Support Team Once a subject is enrolled in a study, it is very important to continue engaging with and supporting enrolled participants, Characteristics of a Great Recruitment Team Member • Strong Communication Skills • Empathy & Patient-Centric Approach • Attention to Detail • Team Collaboration & Interdisciplinary Approach • Adaptability & Problem-Solving/Critical Thinking Marketing Team Checklist Link Marketing Essential Job Duties The Marketing Team bridges the gap between clinical research processes and the public, ensuring effective recruitment, engagement, and representation of the company. Their multifaceted role encompasses strategic planning, customer engagement, and digital outreach. Recruitment & Advertising Digital & Traditional Marketing • Design study-specific recruitment plans and strategies. • Oversee website content, SEO, and management. • Manage ad creation, listing sites, and study-specific portals. • Curate and manage social media pages, content, and • Utilize various platforms: Craigslist, Center Watch, DBSA, etc. Customer Engagement & Satisfaction • Uphold customer service standards and handle various scenarios. • Monitor patient satisfaction, placebo effects, and feedback mechanisms. engagement. • Create and distribute monthly newsletters, blogs, text, and email blasts. Events, PR & Branding • Plan and execute company events, meetings, and PR activities. • Handle press releases, media relations, and maintain Recruitment Team Recruitment Essential Job Duties Recruitment Staff play a pivotal role in identifying, engaging, and ensuring the suitability of participants for clinical trials. Their responsibilities encompass candidate assessment, effective communication, logistical coordination, compliance adherence, and collaborative efforts with other departments toCollaboration achieve recruitment goals & Reporting Candidate Screening & Eligibility • Understand and apply inclusion & exclusion criteria for potential study participants. • Conduct detailed pre-screenings via phone or in-person to assess candidate suitability. Engagement & Communication • Interact professionally with potential participants to provide study information and answer queries. • Maintain a database of inquiries, ensuring accurate and timely followups. Coordination & Scheduling • Collaborate closely with the Marketing Team to ensure alignment on recruitment strategies. • Provide regular updates on recruitment metrics, referral tracking, and enrollment status. Training & Compliance • Complete essential training modules, including HIPAA, Good Clinical Practice, and relevant CTMS systems. • Adhere to IRB approval guidelines and ensure all recruitment practices comply with company and regulatory standards. Feedback & Improvement • Gather feedback from participants during the recruitment process to Call Center Call Center Essential Job Duties Call Center Staff are essential in facilitating effective communication between potential participants and the company. Their role encompasses clinical knowledge, customer engagement, scheduling coordination, compliance adherence, collaboration with various departments, and efficient management of call center resources. Clinical Research Knowledge • Understand the company's clinical research overview, trial processes, and roles of sponsors, CROs, FDA, IRB, etc. • Familiarize with inclusion & exclusion criteria for phone pre-screening. Customer Interaction & Engagement • Handle inbound calls professionally, providing information about clinical trials and addressing queries. • Utilize phone pre-screen scripts and diagnosis severity charts to guide conversations effectively. Appointment & Scheduling Management • Schedule, reschedule, or cancel appointments using company calendars and scheduling cheat sheets. • Coordinate transportation requests for participants, as necessary. Training & Compliance • Complete mandatory training modules including HIPAA, Good Clinical Practice, OSHA, and CTMS (RealTime). • Adhere to company protocols for call tracking, referral documentation, and ensuring data accuracy. Collaboration & Communication • Coordinate with the Recruitment Team and other departments, forwarding inquiries as per the provided chart. • Engage in active campaigns, referral programs (e.g., "Refer-a-Friend," "$10 Walmart Card Program"), and central recruitment portals. System & Resource Management • Operate and manage tools such as the XO Phone System, LiveOps, and the Segal Trials email account. • Ensure efficient use of computer resources, email management, and storage while maintaining security protocols. Performance & Feedback • Meet performance expectations, goals, and KPIs related to call handling, appointment scheduling, and participant engagement. • Provide feedback to improve scripts, processes, and overall call center efficiency. Script Link Call Center Script Call Center Phone Script [Step 1] Ensure you have the Call Center Phone Script ready to ask all questions necessary Call Center Phone Script [Step 2] Call Center Phone Script [Step 3, 4 & 5] Call Center Phone Script [Step 6] Call Center Phone Script [Step 7] RealTime CTMS & Recruitment Scheduling Subjects into CTMS • Ensure you have the Call Center Phone Script ready to ask all questions necessary • Before creating an account for a patient, ask whether the patient has ever been to Segal Trials. Once you get the patient’s permission, enter their date of birth into the “Subject Search" • Existing Patient: verify all the information in the patient’s “Subject Profile” is up to date and correct, as well as the “Medical History” and “Meds & Treatments Tab” • New Patient: verify all information being entered into CTMS while the patient is on the phone (spelling of the patient’s name should be repeated back using the NATO phonetic alphabet) Scheduling Subjects into CTMS • Existing Patient: verify all the information in the patient’s “Subject Profile” is up to date and correct, as well as the “Medical History” and “Meds & Treatments Tab” • New Patient: verify all information being entered into CTMS while the patient is on the phone (spelling of the patient’s name should be repeated back using the NATO phonetic alphabet) • Alfa, Bravo, Charlie, Delta, Echo, Foxtrot, Golf, Hotel, I ndia, Juliet, Kilo, Lima, Mike, November, Oscar, Papa, Scheduling Subjects into CTMS •Once you have completed the script, and based on the patient’s responses, the patient is qualified to pre-screen. You will first need to change the patient’s recruitment status for that trial to “Schedule for Pre-Screen” (make sure you click update so that the “Schedule Pre-Screen” option shows up •You will want to have the site’s calendar open, in which you will schedule the patient. To switch the site calendar you are viewing, go to “Calendar” and at the top of the page, you can pick the site from the drop-down: Creating Subject Profiles in CTMS: •Once you have the calendar open and the patient has decided a date and time they would like to come in, the pop-up window that came up when you clicked “Schedule Pre-Screen” will have a “Start Date: Time” that you will need to update. (Make sure that the assigned calendar is correct and always make sure it says “Company Calendar” and “My Calendar” ) •Make sure to hit “Save Event & Close” and the appointment will be Creating Subject Profiles in CTMS: • As you are reading the script, please make sure to enter the information in CTMS as you get the subject’s responses. • Whether you look up the patient (if they have an existing profile) or if you are creating a new profile all information must be confirmed with the subject **It is important to enter/update all medical history as this information may be used by clinicians and the recruitment team for future trials consideration** Recruitment Status Explained • “Not Contacted” – new lead that should be contacted within 24 hours of entry into CTMS- once the patient is contacted, the recruitment status should be updated to “CC Contact Attempt 01” • “CC Contact Attempt 01, CC Contact Attempt 02 and CC Contact Attempt 03” – this is changed each time the patient is contacted. • “Unable to Contact” – after the third contact attempt, “CC Contact Attempt 03” the call center representative should Recruitment Status Explained (continued…) • • • “Phone Prescreen” – subject is scheduled for a phone pre-screen and e-mail is sent to “All Raters” (e-mail format is available within the format section of this manual) “Continue Prescreen”- the rater is still reviewing the patients prescreen. If a patient calls in and has this as their recruitment status, please let them know you will contact the rater for the patient to receive a f/u and proceed accordingly. “Scheduled for Pre-Screen”, Recruitment Status Explained (continued…) • “No-Show Screen”- patient did not show for Screening • Visit • documentation SHOULD RATER ONLY OR BE RESCHEDULED CLINICAL BY A • “Cancelled”- patient cancelled appointment, needs to be rescheduled • “DNQ (add comment)”- patient DOES NOT QUALIFY. parent/caregiver/legal “Call Center Waitlist”- subject’s recruitment status yet open or if we do not currently have a trial for the WHO SCHEDULED THE PATIENT • the should be updated to this status if the study is not RESCHEDULE, REFER TO THE RATER/CRC prescreen and needs to be rescheduled. as has MRN of the opposite account into each account. DID NOT SHOW FOR A SCREEN CALLS TO “No-Show Prescreen” – patient did not show for Guardian/Caregiver”- guardian for the subject. Make sure to include the RESEARCH COORDINATOR (CRC)– IF A PATIENT WHO • “Parent/Legal patient’s indication. • “Qualified Waitlist”- this status is used by the rater group only, to place subjects on a waitlist during the time period, before the trial opens. If a patient calls and their current recruitment status is Qualified Color Code Guide Using CTMS to Find Leads for Outbound Calls • Each trial on CTMS will have subjects divided into the different recruitment status categories. • Patients with a recruitment statuses listed below, need to be contacted. • “CC Contact Attempt 1” • “CC Contact Attempt 2” • “CC Contact Attempt 3” “Not-Contacted” Status Patients who have expressed interest in our studies through our website, or patients with a “Not-Contacted” status that has been added within the past 7 days will be on a red profile image on the top right-hand corner of CTMS: Appointment Documentation Reminders • If a patient is scheduled for a phone pre-screen, an on-site pre-screen or a screen (currently only applies to STI studies) the call center representative must document this information in the “Contact Attempts Section” of the patient • Any phone prescreens should have an updated recruitment status of “Phone Pre-screen" • Phone Prescreens should be sent in an e-mail to the “All Raters” Group and should include “Call Center Manager, Erin Tireman, Kate Templeton and Autumn Birch” in the CC section of the e-mail. The format for the e-mail should be as follows: • E-mails for phone prescreens should be sent immediately after scheduling the patient, to ensure that the raters can contact the patient within the allotted time frame • Inform the patient that a clinician will call them within 24-48 hours (due to the number of Spanish clinicians, please quote 72 hours for Spanish speaking patients who are scheduled for phone prescreens) • Subject line: Phone Prescreen Indication (SPANISH- only to be included for Spanish only subjects) • In your message, include the patient’s information from CTMS and describe any reasons that this person was scheduled as a phone prescreen, as applicable • If you are rescheduling an appointment that No-Show or Cancelled, make sure to change the “Event Status” and “Color Code” of the appointment accordingly • If you call a No-Show and you are unable to get in touch with them, change their recruitment status to “No-Show”. If the recruitment status is already “NoShow Pre-Screen” then change it to “CC Contact Attempt 01” • If subject is on a “Call Center Waitlist” and you are scheduling them to screen, change their recruitment status to “Scheduled for Screen” and then schedule. DO NOT SCHEDULE AS A F/U. • Every time a patient is contacted on CTMS it MUST BE DOCUMENTED IN CTMS CONTACT ATTEMPTS. This applies whether you schedule the subject, left a voicemail or the patient calls in for whatever reason. Sending E-mail & Texts to Subjects If the patient has an e-mail address on file, or from a lead, please follow the following format when sending the message to the patient: Subject Line: A Paid Clinical Research Study for You Message: Good Afternoon, Thank you for your interest in our depression study. We’re happy you took the time to inquire about your health and we’re here to help! My name is Call Center Representative’s Name and I would be happy to answer any of your questions. We have many studies available throughout South Florida and South Carolina and we can identify which one works best for you or your family member! Please call me or email me at Call Center Representative’s E-mail to schedule an appointment. If you are unable to call us, please email me and we can schedule an appointment to see if you qualify. No insurance is necessary! Compensation is available if qualified. Transportation may be provided. You’ll even receive a $35 gift card just for coming in to see if you qualify! If you have a friend or family member who may be interested in one of these trials, please have them contact us. You may be eligible to receive $50 for each person you refer who enrolls in a study per our Refer-A-Friend Program. Please note that this program does not apply to all studies. The person you refer will just need to complete the Refer-A-Friend form during their first visit. https://www.segaltrials.com/refer/ Refer A Friend | Segal Trials | Segal Institute for Clinical Trials<https://www.segaltrials.com/refer/> www.segaltrials.com Segal Trials is a network of research sites comprised of numerous physicians and offices throughout South Florida and South Carolina conducting Phase I-IV research trials. Refer A Friend | Segal Trials | Segal Institute for Clinical Trials<https://www.segaltrials.com/refer/> www.segaltrials.com Segal Trials is a network of research sites comprised of numerous physicians and offices throughout South Florida conducting Phase I-IV research trials. I look forward to hearing from you soon! Ofrecemos estos estudios en español, Llama ahora! 1-877-734-2588 • To send a subject a text through CTMS, go to the subject's profile and write a message in the contact attempts section. Change the “Contact Outcome” to either Unsuccessful Contact Attempt or Appointment Reminder, and then check the box “Send as SMS Text to Subject” and Click Update Reference Materials 6 Qualities Every Customer Service Agent Should Have 1.Positive Attitude: 4. Ability to Improvise: 1. Easier work with confidence. 1. Handling difficult situations. 2. Motivated through training and 2. Adaptation for individual customer mentoring. 2.Great Listening Skills: 1. Important customer insights. 2. Providing ease in difficult situations. 3.Strong Multitasking Skills: 1. Handling data, peer needs. 5.Empathy: 1. Connecting with customers emotionally. 2. Showing understanding and proposing optimal solutions. 6.Deep Understanding of the Brand: Link to Arti 2. Mastering technology, regular cle 2. Alerting customers if placed on training. communication, and customer dialogue simultaneously. 1. Knowing products/services. 6 Steps for Resolving a Customer Issue 1.Listen and Assess: 1. Real-time channels: Let the customer explain. 2. Other channels: Assess and involve relevant departments. 2.Take Responsibility: 1. Show empathy. 2. Use proper language and genuine respect. 3.Reassure by Describing Solution: 1. Detail the course of action. 2. Provide options when possible. 4. Deliver on Promise: 1. Act immediately. 2. Offer extra perks (e.g., expedited shipping). 5.Follow Up: 1. Update on the solution. 2. Seek customer satisfaction feedback. 6.Make Problem-Solving a Company Effort: Link to Arti company-wide. 2. Collaborate on strategies for cle 1. Discuss customer concerns Diagnosis by Severity Medication Guide Bipolar/Schizophrenia/ Schizoaffective Depression Opiate Use Disorder •bilify, generic: Aripiprazole •Buspar, generic: Buspirone •Fentanyl •Carbamazepine •Celexa, generic: Citalopram •Heroin •Clozaril, generic: Clozapine •Cymbalta, generic: Duloxetine •Hydrocodone •Depakote, generic: Divalproex Sodium •Effexor, generic: Venlafaxine •Morphine •Geodon, generic: Ziprasidone •Elavil, generic: Amitriptyline •Oxycodone/ Oxycontin •Haldol, generic: Haloperidol •Klonopin, generic: Clonazepam •Morphine •Invega, generic: Paliperidone •Lexapro, generic: Escitalopram •Percocet •Lamictal, generic: Lamotrigine •Paxil, generic: Paroxetine (**Does not include Methadone, •Latuda, generic: Lurasidone •Prozac, generic: Fluoxetine Suboxone, Subutex or •Lithium •Remeron, generic: Mirtazapine Buprenorphine as these are for •Risperdal, generic: Risperidone •Temazepam treatment of OUD**) – •Seroquel, generic: Quetiapine •Trazodone May need patients on these •Thorazine •Wellbutrin, generic: Bupropion medications so it is very important •Zyprexa, generic: Olanzapine •Xanax, generic: Alprazolam that this information is documented •Zoloft, generic: Sertraline in CTMS Daily Report Format (for Call Center) Daily Report Format (part Daily Report Format (part 1) 2) Date: Notes: Calls Handled: Appointments: -On-site= -Phone Prescreens= - Inbound= Waitlists Total= - Outbound= DNQ Total= Leads of Outbound Calls: Issues with Vonage: Issues with CTMS: Frequently Asked Questions (for Patients) 1) What exactly does Segal Trials do? • We conduct a multitude of clinical trials, mostly for Psychiatric and Women’s Health indications. Participation would involve taking an investigational medication or using an investigational medical device, depending on the trial. 2) What is a pre-screen? • A pre-screen is an interview you will have with one of our clinicians on site. The interview will involve questions about your medical and your psychiatric history, including any of your past and current diagnoses/medications. 3) What types of trials does Segal Trials offer? • Segal Trials offers outpatient studies with or without an inpatient portion in the areas of Psychology, Neurology and Women’s Health. 4) How long does the pre-screen visit last? • Initially when you come in, you will fill out a demographics packet that will ask you about your medical history, your PCP’s/Psychiatrists info if you have one. Once you fill it out, you will have your pre-screen done. The whole visit can take about an hour. 5) Why can’t I apply for another study (patient’s who have had a pre-screen in the past 90 days)? • The reason is because we don’t have any new trials from the last time you applied. When you came into pre-screen, you were cross-examined for any current and upcoming trials. 6) If I don’t have an ID card, (government issued ID) what can I bring instead? Frequently Asked Questions (for Patients) 7. When will payment be on my card? • Payment will be loaded onto the card given to the patient every Monday, following your appointment, by 5 pm. Note that this varies depending on the study. • **(may need to refer the patient to their CRC for questions/issues)** 8.How would I receive payment, if I were to get into a study? • Your payment would be loaded onto a debit card that is assigned to you by your study coordinator. It is like a Visa card. 9.How long do the studies last? • That depends on the trial that the clinician sets you up to screen for. Trials vary in duration and can last anywhere from 1 week to even 3 years, so this is important information given by the clinician. 10.Can I set up an appointment for a Depression and Schizophrenia study? • When you come in for your pre-screen, the clinician will cross examine and review your medical and psychiatric history to determine which one of our trials you are the best fit for. 11.How does refer-a-friend work? • If you refer a friend to a trial, once that patient has a pre-screen done if they qualify, and randomize, then two weeks after their randomization you should receive $50 for your referral. Refer-a-friend is for randomized patients. 12.What is the status of my pre-screen? • If the patient DNQ, please let them know that you will forward their information to the clinician who did their prescreen for follow up. 13.Does Segal Trials provide transportation for pre-screen visits? • Currently, we are not providing transportation for pre-screen visits. Once you qualify for a trial, you can receive free transportation to and from your visits with us. Important General Reminders • If patient was scheduled to screen for a psychiatric indication, DO NOT RESCHEDULE THE PATIENT. Please forward the patient’s information to the staff at the site of their screen. • If a patient lives over 2 hours away, please let this patient know for inpatient/outpatient studies that they would not be able to participate due to the frequency of the visits and refer them to our website for other clinical trials in their area, or clinicaltrials.gov. • If you find a patient with a duplicate/several accounts, send an e-mail to Erin Tireman, Kate Templeton and CC the Call Center Manager. Make sure you pinpoint which account is most upto date and note this in your e-mail. • If a patient calls in, and already has a profile in CTMS, please make sure to update all the information in the patient’s “Subject Profile”, “Medical History” and “Meds & Treatments” What to do if Patient Reports Suicidal Ideation • If a patient reports any suicidal thoughts while you are on the phone with them, please refer to this flyer by STARR 911. This flyer will assist and guide you in the event that a patient does not qualify and reports suicidal ideation on the phone with you: Pre-Screening Script Link Pre-Screening Essential Job Functions The Pre-screening Team plays a pivotal role in evaluating potential study participants, ensuring they meet specific criteria and ethical standards. Their responsibilities encompass in-depth clinical research knowledge, accurate candidate assessment, effective communication, compliance adherence, collaboration with recruitment teams, and continuous process improvement to support the company's goals and objectives. Documentation & Reporting • Maintain accurate and detailed records of all pre-screening activities, evaluations, Clinical Research Proficiency and participant interactions. • Thoroughly understand the company's clinical research processes, protocols, and criteria for study participation. notable trends or insights. • Implement and apply detailed inclusion & exclusion criteria during participant evaluations. • Conduct comprehensive screenings of potential study participants to participant transitions and maintain consistent communication. • Provide feedback and insights to improve pre-screening processes, tools, and ensure eligibility. • Collect and review necessary documentation, medical histories, and other relevant information for accurate pre-screening. with potential participant engagement strategies. Quality Assurance & Improvement Communication & Feedback effectively Collaboration & Coordination • Collaborate closely with the Recruitment and Call Center Teams to streamline Candidate Assessment & Verification • Interact • Generate reports on pre-screening outcomes, participant eligibility rates, and any • Ensure the quality and integrity of pre-screening activities through regular reviews participants, providing clear information about study requirements, expectations, and next steps. • Communicate findings, eligibility decisions, and recommendations to the Recruitment Team and relevant stakeholders promptly. and adherence to established protocols. • Continuously seek opportunities to enhance efficiency, accuracy, and participant satisfaction within the pre-screening process. Pre-Screening Basics • What is a pre-screen? • A "pre-screen" is the initial evaluation process conducted before potential participants undergo formal screening for eligibility in a clinical trial. The purpose of the pre-screen is to quickly assess whether an individual might meet the basic criteria required for participation in a specific clinical trial. • During the pre-screening phase, researchers typically collect preliminary information from potential participants. This may include basic demographic information, medical history, current medications, and other relevant details that allow the research team to Psychiatric Assessment/ Hospitalization Do you have any psychiatric diagnoses? Hospitalization: If yes: what diagnosis? When were you Have you ever been admitted to a diagnosed? psychiatric hospital? If yes OR no: If yes: Are you currently taking any psychiatric • How many times in your lifetime? medications? • When was the last time? If yes: Name of medications? Dose & frequency? • Most recent time? Start date? Are you taking as prescribed? • Why were you admitted? If yes OR no: If no: continue the pre-screen • Any past medications? (most recent past meds are likely the most important to know) • Names (if known) • Start/stop dates (if known) Suicide History Have you ever attempted suicide? If yes: • How many times? • When was the last time? • What happened/what did you try to do? • Did you stop yourself or did someone stop you? Or did you follow through? • Were you hospitalized after? Have you every had any suidical thoughts or impulses? Plan? Intent? Passive thoughts? • If yes: when was the last time you had these suicidal thoughts/impulses/plan/intent/passive thoughts? Substance Use/Abuse • Nicotine use? • Alcohol use? • Marijuana use? • Cocaine use? • Opiates/Heroin/Fentanyl use? • Psychedelic substances? • If yes: What is the number of times used throughout life? • Unprescribed Benzos? • Any other substances that are not prescribed? • *Need to know these details related to their substance use: • How often? • When was the last time used? • When did you start using? How often? • Depending on the substance: smoke, snort, inject? • Have you ever been to treatment or rehab for drug or alcohol use? If yes: When? What for? Inpatient or outpatient? Are they currently in treatment (Tx)? Legal History Any past or ongoing legal issues? Court cases? Probation? If yes: Court dates? Would probation officer allow you to be involved/travel/come inpatient? Previous Studies Have you ever been in or are you currently in any research studies? If yes: When was that? What for? Did you take medication? Did you complete the study? Symptom Presentation Need to ask for ALL PRE-SCREENS: If applicable, ask about: • Psychosis • PTSD • Depression • ADHD • Mania • GAD/SAD/Panic • Current suicidality • OCD • BED • BPD Symptoms should be assessed for ANY suspected disorder/diagnosis • Substance abuse • (Have they ever overdosed? Do they have withdrawal symptoms? Symptom Presentation (continued) *Need to know: • Frequency • Intensity • Duration of symptoms • Interference of symptoms When symptoms section is complete, you should be able to confidently make an ACCURATE diagnosis/know what diagnostic critera subject meets using clinical judgement Once an accurate diagnosis is made, this will allow you to narrow down which studies Pre-screening Guidelines • Current MDE (Major Depressive Episode) • Time frame assessing: Past Week/Past 7 Days • Symptoms to assess for: feeling down/depressed, interest in activities, appetite, sleep, energy, guilt, concentration, apparent sadness • Make sure to establish the start of current MDE • *If Bipolar and currently manic/hypomanic identify last MDE • Mania • Time frame assessing: Past week/past 7 days; if Mania began <7 days ago assess since start of episode • Symptoms to assess for: increase in energy, elevated mood, irritability, fights/arguments, increased sense of self, sleep, impulsivity, racing thoughts, Pre-screening Guidelines (continued…) • PTSD • Identify Index Trauma – if subject endorses multiple traumas identify the primary and only assess symptoms related to the event • Time framing assessing: Past Month/Past 30 Days • Symptoms to assess for: unwanted memories, flashbacks, hypervigilant, nightmares, sleep disturbances, irritability, concentration, avoidance of thoughts/feelings, avoidance of places/people, physical reactions, feeling distant or cut off • Schizophrenia • Time frame assessing: Past Week/Past 7 Days • Symptoms to assess for: hallucinations (visual, auditory, tactile, olfactory), paranoia/suspiciousness (trust, spy/plot), grandiosity (feeling better than others, special powers/abilities), delusions, anxiety, depression, hostility, conceptual disorganization • Remember if any subject is denying symptoms in the past 7 days, that does NOT mean they do not meet criteria for schizophrenia. Assess if subject has ever experienced psychotic symptoms and consider current Other Pre-Screen Basics to Consider • Keep in mind, we are assessing for ALL STUDIES when pre-screening • Although a subject may have a diagnosis, they may not necessarily meet diagnostic criteria (past or present) for that diagnosis • Consider the entire overall profile before reaching an outcome • We want to get as much information in as little time possible • Familiarizing self with protocols and common inclusion/exclusion criteria will be VERY helpful, but Common Questions for a PS • Will I have to take a medication? • How much will I get paid? • Is my information confidential? • Do I qualify? • After this, what happens next? Patient Retention Patient Retention Essential Job Functions The Patient Retention Team focuses on maintaining participant engagement, satisfaction, and adherence throughout their involvement in clinical trials. Their responsibilities encompass communication, support, coordination, education, compliance, and collaboration to enhance participant retention, satisfaction, and overall study success. Participant Engagement & Communication Retention Strategies & Initiatives • Establish and maintain regular communication channels with enrolled • Develop and implement retention strategies, initiatives, or programs tailored to participants to ensure satisfaction, address concerns, and provide support. • Build rapport and trust with participants to foster a positive relationship throughout their involvement in clinical trials. participant needs, preferences, and feedback. • Monitor participant retention rates, identify trends, and implement targeted interventions or support measures, as necessary. Feedback & Support Compliance & Ethical Standards • Collect feedback from participants regarding their experiences, • Ensure adherence to ethical standards, regulatory requirements, and company concerns, and suggestions for improvement. • Address participant inquiries, challenges, policies related to participant retention and engagement. or issues promptly, collaborating with relevant teams or departments as needed. Educational Resources & Guidance • Provide participants with relevant educational materials, resources, or guidance related to their specific clinical trial. • Address questions about study protocols, procedures, expectations, and potential side effects to enhance participant understanding and compliance. • Collaborate with IRB, sponsors, CROs, and other stakeholders to maintain compliance and uphold participant rights and welfare. Reporting & Collaboration • Generate regular reports on participant retention metrics, challenges, successes, and recommendations. • Collaborate closely with the Recruitment, Pre-screening, and Clinical Teams to facilitate seamless transitions, continuity of care, and participant satisfaction Questions & Answers Thank you