Compliance and Risk Management

Teaches protection of participant identity, sensitive clinical or occupational information, recordings, and research data. The competency covers coded identifiers, restricted access, secure handling, confidentiality safeguards, and privacy-preserving documentation.

6 care stages · 53 guidelines · 0 courses · 0 providers

Teaches how to detect, elicit, document, and report adverse events and serious adverse events across the participant journey. The focus is accurate source documentation, regulatory reporting discipline, follow-up, and preservation of participant safety and trial integrity.

7 care stages · 46 guidelines · 0 courses · 0 providers

Teaches faithful delivery of manualized treatment and protocol-defined procedures while documenting and managing unavoidable deviations. The competency protects participant welfare, treatment consistency, data integrity, and sponsor oversight.

7 care stages · 39 guidelines · 0 courses · 0 providers

Teaches how to preserve blinded trial conduct across participant interactions, outcome collection, staff roles, and session procedures. The competency includes preventing accidental unblinding, minimizing bias, and using emergency unblinding only when clinically necessary.

8 care stages · 29 guidelines · 0 courses · 0 providers

Able to practice ethically in a clinical trial environment involving a Schedule-sensitive psychoactive intervention. This includes protecting participants, adhering to protocol, and supporting valid informed participation.

7 care stages · 16 guidelines · 0 courses · 0 providers

Teaches adherence to Good Clinical Practice, assigned study roles, protocol procedures, delegation boundaries, and applicable research regulations. The competency supports consistent execution of approved procedures across sites and participants.

5 care stages · 15 guidelines · 0 courses · 0 providers

Teaches how to instruct participants on post-dose and study-period restrictions that reduce risk from impaired judgment, unsafe activity, prohibited substances, or behaviors that could confound study outcomes.

6 care stages · 8 guidelines · 0 courses · 0 providers

Therapists and study personnel are expected to receive structured training and ongoing supervision. Competence includes both protocol adherence and the ability to work safely and consistently across sites.

6 care stages · 8 guidelines · 0 courses · 0 providers

Understands that MDMA is a Schedule 1 investigational product and must be stored, dispensed, and accounted for under regulatory control. Supports compliant handling during the session.

4 care stages · 4 guidelines · 0 courses · 0 providers

The manual specifies baseline professional requirements for study therapists. These include licensure and substantial clinical experience with psychiatric populations.

3 care stages · 3 guidelines · 0 courses · 0 providers

Know the sequence, timing, and purpose of screening, preparation, dosing, scanning, follow-up, and unblinding visits. The therapist/facilitator must be able to work within the full protocol structure.

6 care stages · 3 guidelines · 0 courses · 0 providers

Teaches practitioners to identify and apply relevant legal, regulatory, ethical, and institutional requirements, including documentation, consent, reporting, controlled-substance, and jurisdiction-specific obligations.

7 care stages · 2 guidelines · 2 courses · 2 providers

Engages in ongoing supervision and accepts feedback to maintain treatment quality. Supports corrective action when performance is unsatisfactory.

2 care stages · 2 guidelines · 0 courses · 0 providers

Therapists must practice within the population and setting defined by the manual, limiting use to approved clinical trial subjects with PTSD. This boundary helps protect participants and preserves research integrity.

2 care stages · 2 guidelines · 0 courses · 0 providers

The intervention involved two separate psilocybin dosing sessions 3 weeks apart under a randomized controlled protocol, implying the need for facilitators to reliably support treatment according to a fixed schedule and study procedures.

4 care stages · 2 guidelines · 0 courses · 0 providers

Therapists/facilitators must fulfill professional legal duties and escalate safety or reporting concerns promptly.

3 care stages · 2 guidelines · 0 courses · 0 providers

Understands the optional nature and operational limits of biomarker and pharmacogenomic collection. Ensures consent, timing, fasting guidance, and sample handling requirements are respected.

3 care stages · 2 guidelines · 0 courses · 0 providers

Therapists must meet licensure requirements and work within supervision structures appropriate to their training and role. Unlicensed or PAP-inexperienced staff require direct supervision.

3 care stages · 2 guidelines · 0 courses · 0 providers

Lead therapists must hold appropriate licensure and regulatory registration to provide psychotherapy, and have prior PAP experience. Unlicensed or inexperienced therapists may participate only under direct supervision.

2 care stages · 2 guidelines · 0 courses · 0 providers

Clinical investigators must work within independent safety monitoring structures and avoid conflicts in oversight roles. Therapists/facilitators in research settings should support scheduled review of participant safety outcomes.

2 care stages · 2 guidelines · 0 courses · 0 providers

Deliver comparable behavioral support across psilocybin and NRT conditions while respecting protocol differences. Facilitators must maintain treatment fidelity and avoid bias toward one arm.

2 care stages · 2 guidelines · 0 courses · 0 providers

Work within a supervised treatment model that includes review of recorded sessions and feedback. The facilitator must accept supervision, use feedback constructively, and support fidelity reviews.

2 care stages · 2 guidelines · 0 courses · 0 providers

Lead facilitators were doctoral-level psychologists or physicians with major depressive disorder treatment experience, and co-facilitators had at least a bachelor’s degree in a mental health-related field. The source therefore indicates role-appropriate clinical background and experience requirements.

2 care stages · 1 guidelines · 0 courses · 0 providers

Understand the transition from blinded randomized treatment to open-label MDMA-assisted therapy for eligible participants. This includes separate consent, revised scheduling, and altered assessment timing.

3 care stages · 1 guidelines · 0 courses · 0 providers

Identifies and reports device deficiencies and product quality complaints related to the nasal spray device or product packaging. Ensures immediate escalation when malfunctions or labeling issues occur.

1 care stage · 1 guidelines · 0 courses · 0 providers

Document eligibility decisions, registrations, and protocol compliance accurately and completely. This includes signed checklists, source documentation, and investigator attestation.

1 care stage · 1 guidelines · 0 courses · 0 providers

Those organizing sessions should understand the legal implications of ayahuasca in their jurisdiction. This helps them manage accountability and reduce legal risk.

2 care stages · 1 guidelines · 0 courses · 0 providers

Adheres to organizational code of ethics, privacy policy, electronic communication policy, and applicable laws. Maintains professional conduct across contractor and clinic arrangements.

2 care stages · 1 guidelines · 0 courses · 0 providers

Expectation that study personnel are trained in research ethics and responsible conduct of research. This underpins appropriate consent, confidentiality, and participant safety practices.

2 care stages · 1 guidelines · 0 courses · 0 providers

Therapists/facilitators must adapt practice to protocol improvements and revised treatment procedures introduced through IRB recommendations.

1 care stage · 1 guidelines · 0 courses · 0 providers

Can determine whether a study record actually specifies therapist/facilitator responsibilities or competencies. This includes distinguishing direct treatment skills from administrative registry instructions.

1 care stage · 1 guidelines · 0 courses · 0 providers

Ability to recruit participants using approved procedures while respecting privacy, documented preferences, and limits on contact attempts. Recruitment must avoid coercion and unauthorized disclosure.

1 care stage · 1 guidelines · 0 courses · 0 providers

Ability to recognize when a source does not provide enough information to infer clinical safety responsibilities or therapist competencies. This prevents unsupported claims about monitoring or intervention delivery.

1 care stage · 1 guidelines · 0 courses · 0 providers

Clinicians must ensure participants meet day-of-session safety requirements before psilocybin is administered. This includes verifying toxicology, pregnancy, alcohol abstinence, and adherence to protocol restrictions.

3 care stages · 1 guidelines · 0 courses · 0 providers

Supports rigorous conduct of randomized controlled safety studies by maintaining protocol adherence and minimizing bias. Protects the validity of safety, tolerability, and exploratory efficacy assessments.

3 care stages · 1 guidelines · 0 courses · 0 providers

Operate within a shared management plan so that all team members respond consistently during routine care and emergencies. The guideline emphasizes coordinated actions, not ad hoc improvisation.

1 care stage · 1 guidelines · 0 courses · 0 providers

Operate only within the bounds of formal training, supervision, and site authorization. The protocol expects specialized training for facilitators, raters, and all staff interacting with participants or data.

1 care stage · 1 guidelines · 0 courses · 0 providers

Facilitators must know the study timeline to conduct therapy and safety checks at the correct times. They should understand which visits are in person, virtual, or questionnaire-only and what assessments occur at each stage.

5 care stages · 1 guidelines · 0 courses · 0 providers

Because this is a randomized controlled trial comparing ketamine with active placebo, clinicians must respect trial procedures that protect scientific integrity and participant welfare. This includes adherence to allocation procedures and avoiding actions that could compromise blinding.

1 care stage · 1 guidelines · 0 courses · 0 providers

Teaches practitioners to read and understand clinical protocols, treatment manuals, and evidence-based psychedelic care procedures. The focus is knowing how protocol requirements shape preparation, dosing, integration, documentation, and safety responsibilities.

5 care stages · 0 guidelines · 2 courses · 2 providers

The page repeatedly emphasizes integrity, compliance, and collaboration with professional organizations and researchers. Learners are expected to practice within evolving regulatory and clinical standards.

1 care stage · 0 guidelines · 1 courses · 1 providers

The program emphasizes that it prepares people for therapeutic and facilitative roles within a collaborative care framework, not independent medical practice. Learners are expected to understand role boundaries, especially around prescribing and administration.

5 care stages · 0 guidelines · 1 courses · 1 providers

The page repeatedly frames the program as preparing learners for licensure and professional practice in Oregon. Learners are expected to understand practice context, licensure requirements, and professional transitions.

3 care stages · 0 guidelines · 1 courses · 1 providers

The page includes explicit warnings about what graduates can and cannot legally do. Learners are expected to understand scope limits, licensure requirements, and when consultation supervision is needed.

3 care stages · 0 guidelines · 1 courses · 1 providers

The practicum requires placements at pre-approved sites and emphasizes legal and ethical standards. Learners are exposed to different settings, including clinical, retreat, and harm reduction organizations.

3 care stages · 0 guidelines · 1 courses · 1 providers

Teaches structured assessment of suicidal ideation, intent, psychiatric deterioration, and related high-risk presentations. Learners are trained to use appropriate tools, safety planning, emergency contacts, clinician access, and escalation pathways when risk is identified.

7 care stages · 41 guidelines · 1 courses · 1 providers

Teaches review and management of concomitant medications, restricted therapies, prohibited substances, washout periods, tapering requirements, and abstinence expectations. The competency includes participant counseling, medication reconciliation, sponsor notification, and team coordination when restrictions affect safety or interpretability.

7 care stages · 29 guidelines · 0 courses · 0 providers

Teaches accurate study documentation, source-record quality, secure data capture, Good Clinical Practice recordkeeping, IRB and sponsor documentation requirements, monitoring readiness, audit support, accountability, and retention obligations.

8 care stages · 27 guidelines · 0 courses · 0 providers

Teaches delivery of psychedelic-assisted psychotherapy according to an approved study manual across preparation, dosing, integration, and follow-up. The competency balances standardized structure with non-directive support for the participant’s therapeutic process.

8 care stages · 25 guidelines · 3 courses · 2 providers

Teaches how to understand ClinicalTrials.gov records and related study information, including glossary terms, registration fields, protocol descriptors, and results-reporting elements used to interpret clinical research records.

5 care stages · 24 guidelines · 0 courses · 0 providers

Clinicians and research staff must clearly educate participants about study procedures, risks, side effects, restrictions, and possible benefits, and obtain written informed consent before screening and study participation. Ethical delivery depends on transparent communication and opportunities for questions.

6 care stages · 5 guidelines · 0 courses · 0 providers

Can identify and involve support persons, attendants, and outside providers to enhance safety. The facilitator must coordinate practical supports while respecting confidentiality and protocol boundaries.

6 care stages · 5 guidelines · 0 courses · 0 providers

The facilitator must administer and coordinate patient-rated and clinician-rated measures while minimizing bias. Assessments should be completed independently and in the correct order.

4 care stages · 4 guidelines · 0 courses · 0 providers

Study clinicians are responsible for administering study drug, ensuring correct dose assignment, and supervising safe oral ingestion during blinded sessions. This includes verifying visit-specific randomization information and ensuring dosing is delivered under the blinded workflow.

3 care stages · 4 guidelines · 0 courses · 0 providers

Participant safety and wellbeing must take precedence over scientific objectives at all times. Therapists must communicate and operationalize this priority throughout screening, treatment, and follow-up.

4 care stages · 4 guidelines · 0 courses · 0 providers

Teaches the use of independent or blinded assessors to reduce expectancy and observer bias, preserve separation between therapeutic and rating roles, manage unblinding risks, and protect outcome validity in open-label or partially blinded designs.

3 care stages · 3 guidelines · 0 courses · 0 providers

Understand how treatment expectations can influence treatment response and study interpretation. Facilitation must avoid inadvertently shaping expectations in a biased or misleading way.

3 care stages · 3 guidelines · 0 courses · 0 providers

Facilitators are responsible for ensuring that participants have provided informed consent before receiving MDMA-assisted therapy. This reflects an ethical and regulatory duty central to work with investigational treatments.

4 care stages · 3 guidelines · 0 courses · 0 providers

Capacity to conduct assessments and therapy sessions virtually when needed while preserving safety and confidentiality. The study permits telehealth sessions for certain visits and contingencies.

4 care stages · 3 guidelines · 0 courses · 0 providers

Therapists must coordinate with prescribing clinicians and existing psychotherapists when relevant, while respecting consent and confidentiality. Communication should support safety, continuity, and protocol integrity.

3 care stages · 2 guidelines · 0 courses · 0 providers

The review explicitly discourages clinical development based on toad venom because of ethical and ecological concerns. Facilitators should favor synthetic sources and avoid practices that could harm wildlife or ecosystems.

2 care stages · 2 guidelines · 0 courses · 0 providers

Deliver manualized Prolonged Exposure therapy according to the study protocol and standard PE structure. This includes sequencing psychoeducation, in vivo exposure, imaginal exposure, homework review, and relapse prevention across sessions.

2 care stages · 2 guidelines · 0 courses · 0 providers

Therapists should accurately represent the current evidence base and avoid overstating efficacy or durability. The article notes significant short-term benefit but also the need for larger multicenter trials and longer follow-up.

2 care stages · 2 guidelines · 0 courses · 0 providers

The protocol explicitly addresses the risk of undue influence when investigators recruit current or former patients, requiring safeguards and ongoing monitoring for coercion.

3 care stages · 2 guidelines · 0 courses · 0 providers

Ability to manage the study schedule, windows, and follow-up procedures accurately. This supports treatment delivery and valid outcome collection.

4 care stages · 2 guidelines · 0 courses · 0 providers

Teaches clinicians to recognise their role boundaries, align services with training, licensure, supervision, and organisational policy, and refer or escalate when participant needs fall outside their scope of competence.

5 care stages · 1 guidelines · 3 courses · 2 providers

Ensure required abstinence conditions are met before dosing and make clinical judgments about rescheduling or exclusion when they are not. This protects safety and protocol integrity.

4 care stages · 1 guidelines · 0 courses · 0 providers

Administer study assessments in the correct order and in the correct format. The protocol depends on reliable, standardized administration by trained site personnel and central raters.

3 care stages · 1 guidelines · 0 courses · 0 providers

Demonstrate standardized rating competence and maintain reliable measurement over time. The protocol emphasizes training, calibration, and ongoing checks to prevent drift.

1 care stage · 1 guidelines · 0 courses · 0 providers

Ability to contribute to evaluation of the effectiveness of LSD-assisted psychotherapy. The study is explicitly described as investigating safety and effectiveness.

2 care stages · 1 guidelines · 0 courses · 0 providers

Therapists and research facilitators should evaluate how participants experienced study involvement, including perceived costs, benefits, and pressure to participate. This reflects an ethical responsibility to monitor the quality and voluntariness of participation over time.

2 care stages · 1 guidelines · 0 courses · 0 providers

Assess whether an event is related to treatment and resolve uncertainty through team discussion and regulatory escalation. The protocol uses a structured causality framework from unrelated to definitely related.

1 care stage · 1 guidelines · 0 courses · 0 providers

At least one therapist in the dyad must be a clinician with capability to assess and manage medical or psychiatric adverse events during the dosing session. This reflects a required competency boundary between general support and clinical responsibility.

3 care stages · 1 guidelines · 0 courses · 0 providers

The training framework explicitly includes cultural awareness and inclusion, and examples identify culturally insensitive behavior as clinically inappropriate.

1 care stage · 1 guidelines · 0 courses · 0 providers

Understands the obligation to follow defined data element standards when submitting or interpreting study information. This is relevant to accurate, non-misleading representation of therapist/facilitator qualifications.

1 care stage · 1 guidelines · 0 courses · 0 providers

Trainers and mentors observe therapists for conduct that could place participants at risk. Therapists must be receptive to correction and able to modify problematic behavior or seek additional training.

1 care stage · 1 guidelines · 0 courses · 0 providers

Responsibility to use study information appropriately and in accordance with registry expectations. This includes respecting the limits of what can be inferred from the record text alone.

1 care stage · 1 guidelines · 0 courses · 0 providers

Manage optional future-contact procedures ethically and separately from current study participation. Participants may choose whether to authorize future contact without affecting present enrollment decisions.

2 care stages · 1 guidelines · 0 courses · 0 providers

Ensure that administration occurs within an ethically supervised research or clinical framework with informed oversight and careful risk-benefit consideration. Hallucinogenic agents require especially cautious use in vulnerable psychiatric populations.

2 care stages · 1 guidelines · 0 courses · 0 providers

Uses a cautious, transparent ethical approach when working with an experimental or non-approved addiction treatment context.

1 care stage · 1 guidelines · 0 courses · 0 providers

Responsibility to use LSD only within an ethically justified, clinically supervised framework. The source does not specify safeguards, but the therapeutic use of a potent psychoactive substance requires careful ethical oversight.

1 care stage · 1 guidelines · 0 courses · 0 providers

Uses publicly available trial information responsibly and within its intended scope. Respects that registry content is not a substitute for clinical judgment, consent procedures, or study-specific training.

1 care stage · 1 guidelines · 0 courses · 0 providers

Responds appropriately to safety threats disclosed in group therapy. Follows up on suicide, homicide, abuse, or neglect concerns and escalates when necessary.

1 care stage · 1 guidelines · 0 courses · 0 providers

Investigators have a continuing duty to inform participants about new findings regarding LSD or LSD-assisted therapy that emerge during the study. This reflects an ongoing consent responsibility rather than a one-time disclosure.

2 care stages · 1 guidelines · 0 courses · 0 providers

Therapists/facilitators must ensure participants are properly informed using approved consent materials before participation in MDMA-assisted psychotherapy research.

2 care stages · 1 guidelines · 0 courses · 0 providers

Exercises heightened ethical responsibility when working with people with opioid dependence undergoing medication changes. Ensures participation remains voluntary, monitored, and clinically appropriate.

2 care stages · 1 guidelines · 0 courses · 0 providers

Therapists must work thoughtfully with the patient's social support system to enhance safety and continuity of care. This includes selective disclosure, education, involvement in sessions when appropriate, and crisis planning.

2 care stages · 1 guidelines · 0 courses · 0 providers

Therapists must know what constitutes adequate prior treatment exposure before considering study enrollment. This requires familiarity with accepted PTSD treatments and minimum duration/intensity standards.

1 care stage · 1 guidelines · 0 courses · 0 providers

Explains the boundaries of confidentiality so patients understand when information may be disclosed without permission. Applies legal and ethical duties related to safety, abuse, and mandated reporting.

1 care stage · 1 guidelines · 0 courses · 0 providers

The facilitator must make repeated documented efforts to contact participants who miss visits. Follow-up processes differ for responders and non-responders.

3 care stages · 1 guidelines · 0 courses · 0 providers

Because study drug delivery uses a vaporization device, staff must be able to recognize, document, and escalate device deficiencies. Device issues may have safety implications even when no patient harm occurs.

2 care stages · 1 guidelines · 0 courses · 0 providers

Sequences study procedures correctly to reduce bias and protect participant safety. Particularly prioritizes PROs, clinician ratings, and dosing-day procedures in the required order.

3 care stages · 1 guidelines · 0 courses · 0 providers

Facilitators are expected to monitor for signs of misuse, diversion, dependence, or other abuse-related phenomena even though the medication is administered only on-site. They must also recognize protocol violations or dropout patterns that may signal abuse liability concerns.

3 care stages · 1 guidelines · 0 courses · 0 providers

Clinicians should present the intervention accurately as ketamine- or midazolam-augmented PE within a research protocol, with clear explanation of purpose and expectations. Ethical practice includes avoiding overstatement of benefit and framing treatment as investigational augmentation of an established therapy.

3 care stages · 1 guidelines · 0 courses · 0 providers

Conduct or support psychiatric screening using clinical interviews and structured diagnostic tools. The goal is to establish baseline mental health status and detect exclusionary disorders or instability.

2 care stages · 1 guidelines · 0 courses · 0 providers

Awareness of the need to use official data element definitions when submitting registration or results information. This reflects adherence to accurate and compliant trial reporting practices.

1 care stage · 1 guidelines · 0 courses · 0 providers

Responsibility to treat study information in a manner consistent with registration and results-reporting requirements. This includes using official definitions rather than improvising field content.

1 care stage · 1 guidelines · 0 courses · 0 providers

Distinguish psychotherapy/facilitation functions from outcome assessment and other research tasks. Separation reduces bias and protects the integrity of blinded assessments.

3 care stages · 1 guidelines · 0 courses · 0 providers

Understands the screening instruments and the respective roles of site staff and independent raters. The facilitator must collaborate with rater findings while maintaining appropriate boundaries and blinding.

1 care stage · 1 guidelines · 0 courses · 0 providers

Administers repeated sublingual microdoses of 5-MeO-DMT in a controlled clinical trial setting. Must follow the assigned dose schedule and maintain blinding across active and placebo conditions.

1 care stage · 1 guidelines · 0 courses · 0 providers

Respect patient autonomy while maintaining safety boundaries during a high-risk intervention. The protocol allowed return to opioid substitution therapy when clinically needed.

1 care stage · 1 guidelines · 0 courses · 0 providers

Therapists should meet formal licensure requirements and have specific prior training and experience in ketamine-assisted psychotherapy. Competence is not generic psychotherapy alone but includes psychedelic/ketamine-specific preparation and familiarity with the study population.

1 care stage · 1 guidelines · 0 courses · 0 providers

The protocol depends on video/audio recordings for later transcription, qualitative coding, and adherence review. Staff must understand how these recordings support both science and supervision.

1 care stage · 1 guidelines · 0 courses · 0 providers

Teaches how participants move through lawful access routes and coordinated care pathways. The competency covers referral navigation, team handoffs, and the practical steps needed to connect eligible participants with appropriate treatment or study settings.

5 care stages · 0 guidelines · 2 courses · 1 providers

The page highlights best-in-class clinical training for drug trials and AI-supported evaluation. Learners are expected to refine skills quickly and receive targeted feedback in training or evaluation contexts.

8 care stages · 0 guidelines · 1 courses · 1 providers

The practicum explicitly says sites cover ethical considerations such as confidentiality, privacy, professional conduct, and ethical decision-making. Ethical alignment is also part of site approval.

2 care stages · 0 guidelines · 1 courses · 1 providers

Learners are guided to earn badges and join a professional directory, showing an emphasis on professional identity, discoverability, and readiness to be found by clients and industry leaders. This is a practice-facing career competency rather than a clinical one.

2 care stages · 0 guidelines · 1 courses · 1 providers

The workshop provides recommendations for obtaining further training, signaling a competency in identifying next-step education and appropriate escalation pathways. This supports responsible scope-of-practice decisions.

1 care stage · 0 guidelines · 1 courses · 1 providers

Trainees receive templates such as consent and intake forms, informational documents, and guidelines, which implies competence in using standardized practice materials. The page also signals procedural support for safe and organized care delivery.

5 care stages · 0 guidelines · 1 courses · 1 providers

The course explicitly states that facilitators are guided in safety, ethics, and responsibility. Learners are expected to recognize and manage the unique risks of working with altered states.

6 care stages · 0 guidelines · 1 courses · 1 providers

Students complete 50 supervised practicum hours and receive expert feedback while working with real clients. This is intended to translate theory into competent applied practice.

7 care stages · 0 guidelines · 1 courses · 1 providers

The course teaches practical steps to launch and sustain a KAP practice, including forging relationships with prescribers and identifying suitable practicum sites. This is framed as part of professional development and business planning.

3 care stages · 0 guidelines · 1 courses · 1 providers