Lesson 3.2 — The Site Team: Delegation and Roles Chapter 3 Lesson 2 30 min Interactive + Quiz Introduction

The Site Team: Delegation and Roles

A clinical trial cannot be run by the PI alone. Every active site relies on a team of people with different qualifications, responsibilities, and boundaries. Understanding who does what, and what each role is permitted to do under GCP, is essential for anyone working in clinical operations.

The team structure at any site must be documented on the Delegation of Authority Log, which we will cover in Lesson 3.3. But before the log, you need to understand the roles themselves: what each person brings, what they are permitted to do, and what only a medically qualified person can authorise.

GCP does not specify job titles. It specifies qualifications and delegated responsibilities. Whether your site calls someone a "Research Nurse," a "Clinical Trial Assistant," or a "Study Coordinator," what matters under GCP is whether that person is qualified for the tasks assigned to them and whether those tasks are properly documented on the delegation log.

Part 1

The Trial Site Team: Roles and Boundaries

Select each role to explore what that team member does, what they are permitted to perform, and what lies outside their scope.

Sub-Investigator Clinical Research Coordinator Research Nurse Trial Pharmacist Data Manager

Sub-Investigator Qualifications Required

Must be a qualified physician, dentist, or other approved healthcare professional as required by the protocol
Current GCP certificate required
Must be listed on the Delegation of Authority Log before performing any delegated tasks

What They Can Do

Conduct participant eligibility assessments and apply inclusion and exclusion criteria
Perform or supervise clinical assessments required by the protocol
Conduct informed consent discussions and sign the consent form as the consenting physician
Assess adverse events for seriousness, causality, and expectedness
Cover the PI's medical responsibilities during planned absences

Limits

A sub-investigator cannot override the PI's decisions or sign documents that require the PI's personal signature. They act under the PI's authority and supervision at all times.

Clinical Research Coordinator (CRC) Qualifications Required

Healthcare, science, or administrative background depending on the role scope
Current GCP certificate required
Protocol-specific training must be documented before performing any study tasks

What They Can Do

Manage the ISF and ensure all documents are filed correctly and on time
Schedule participant visits and coordinate logistics
Enter data into the CRF and respond to data queries
Prepare ethics committee submissions and regulatory documents
Act as the primary point of contact with the CRA during monitoring visits
Maintain the screening and enrolment logs

Limits

The CRC cannot make clinical assessments, assess adverse event causality, or conduct informed consent discussions unless they hold a relevant clinical qualification and are explicitly delegated by the PI. They cannot sign documents requiring a medical degree.

Research Nurse Qualifications Required

Registered nurse qualification with current professional licence
Current GCP certificate
Protocol-specific training documented before performing any study procedures

What They Can Do

Perform clinical procedures within their nursing scope: blood draws, vital signs, ECGs, sample processing
Administer investigational product under PI or sub-investigator supervision if delegated
Assist with participant assessment visits and document findings in source documents
Support the informed consent process by explaining study procedures (though the consenting physician must be medically qualified)
Monitor participant safety and escalate concerns to the PI immediately

Limits

A research nurse cannot make eligibility determinations, assess SAE causality, or conduct the medical part of the consent process. Any task involving a medical judgment must be escalated to the PI or a delegated sub-investigator.

Trial Pharmacist Qualifications Required

Registered pharmacist with a current professional licence
Current GCP certificate
IP-specific training for each trial before handling or dispensing any investigational product

What They Can Do

Receive, store, and maintain the IP accountability log
Dispense investigational product to eligible participants according to the randomisation schedule
Manage returns and destruction of unused IP
Monitor and document IP storage temperature continuously
Prepare unblinded IP for dispensing in blinded trials (with appropriate access controls)

Limits

The pharmacist cannot dispense IP without a valid prescription or dispensing instruction from the PI or delegated sub-investigator. They cannot make clinical decisions about whether a participant should receive IP. Dispensing without authorisation is a critical protocol deviation.

Data Manager Qualifications Required

Data management, life sciences, or informatics background
Current GCP certificate covering data integrity and electronic systems
Training on the specific EDC or eCRF system used in the trial

What They Can Do

Manage the electronic CRF and data entry workflows
Generate and resolve data queries with the site team
Perform data cleaning, coding, and validation checks
Maintain audit trails and ensure data integrity across all data systems
Support the CRC with CRF training and data entry best practices

Limits

A data manager cannot edit source documents or change clinical data without authorisation from the PI. Any data correction must follow the GCP correction process and be traceable. They cannot resolve a clinical data query by making a clinical judgment; those queries must go back to the clinician.

Part 2

Assign the Right Person

When a task needs to be done, it must go to the right team member. For each task below, select the most appropriate role. Some tasks require a medically qualified person; others do not.

Activity: Who Should Do This?

Select the most appropriate team member for each task. Then click Check Answers.

Check Answers 0/8 Part 3

Team Communication Scenarios

Good clinical operations depends not just on knowing roles but on knowing when and how to escalate within the team. For each situation, choose the most appropriate action.

Activity: Escalation and Communication

Five scenarios. Choose the best response for each one.

✓

Knowledge Check

Question 1 of 5 Score: 0 Q 01 A sub-investigator is not on the Delegation of Authority Log yet. A participant arrives unexpectedly and the PI is unavailable. Can the sub-investigator conduct the participant's assessment visit? AYes, because their medical qualification is sufficient even without being on the logA medical emergency is different from a routine assessment visit. In an emergency, any qualified clinician can provide care. But a routine assessment visit is a trial procedure that requires the person performing it to be properly delegated. There is no emergency justification for performing a scheduled trial procedure without delegation. BYes, as long as common sense says they are qualified enoughCommon sense does not override GCP documentation requirements. Without a delegation entry, performing trial tasks is a protocol deviation regardless of how qualified the person is. CNo. The sub-investigator must be added to the DoA Log by the PI before performing any trial task. The visit should be rescheduled or the PI must update the log urgently beforehand.Correct. The DoA Log entry must exist before the person performs any trial task. The visit should be rescheduled if it can safely wait, or the PI should update the DoA Log urgently before the assessment begins. Performing trial procedures without being on the delegation log is a protocol deviation. DYes, if the PI gives verbal authorisation by phoneVerbal authorisation from the PI does not substitute for a DoA Log entry. The delegation must be documented. GCP requires written evidence of delegation, not an oral agreement. Previous Next Q 02 Which of the following tasks requires a medically qualified person and cannot be performed by a CRC or research nurse without a relevant clinical qualification? AEntering participant visit data into the electronic CRFCRF data entry is an administrative task that can be performed by a trained CRC without a clinical qualification. Data accuracy is the PI's responsibility but the entry itself does not require medical training. BRecording daily IP storage temperature readingsTemperature monitoring is a pharmacy or operational task that does not require a medical qualification. A trained pharmacy technician or research nurse can perform it. CAssessing whether an adverse event is serious and causally related to the investigational productCorrect. Assessing whether an adverse event is serious and whether it is causally related to the investigational product requires medical judgment. This task can only be performed by the PI or a delegated sub-investigator who is medically qualified. DFiling monitoring visit reports in the ISFISF filing is an administrative task that can be fully delegated to a trained CRC or site coordinator. It does not require any clinical qualification. Previous Next Q 03 The trial pharmacist receives a dispensing request for a participant but notices the prescription was written and signed by the CRC, not the PI or sub-investigator. What should the pharmacist do? ADispense the IP as requested because the participant is scheduled for the visit todayDispensing based on an unauthorised prescription is a critical protocol deviation. The pharmacist has a professional and GCP obligation to verify that dispensing instructions come from an authorised prescriber. BRefuse to dispense and contact the PI or sub-investigator to issue a correct dispensing instruction before the participant receives any IPCorrect. The pharmacist must refuse to dispense on an unauthorised prescription and contact the PI or sub-investigator to issue a correct instruction. Investigational product may only be dispensed on the authority of a qualified delegated prescriber. The CRC is not authorised to prescribe IP. CCall the CRA and ask for their approval to dispense given the circumstancesThe CRA is not a prescriber and cannot authorise IP dispensing. This decision must come from the PI or a delegated sub-investigator at the site. DFile the prescription in the ISF and proceed next time with the correct processFiling the prescription without dispensing still leaves an unauthorised document in the trial records. The correct action is to contact the PI for a proper prescription, not to file the invalid document as if it were acceptable. Previous Next Q 04 A new CRC joins the site team to support a running trial. What must happen before they can begin performing any trial tasks? AThey can start immediately and complete the paperwork within two weeksStarting work immediately without documentation would mean the CRC is performing undelegated tasks. Any work they do before the DoA Log is updated and training is documented would be a protocol deviation. BThe sponsor must be notified and that notification is sufficient to begin workSponsor notification alone does not authorise the new CRC to perform trial tasks. The DoA Log entry and training documentation must be in place at the site before any tasks begin. CThey must complete GCP training, receive protocol-specific training, and be added to the Delegation of Authority Log by the PI before performing any trial tasksCorrect. Before any trial tasks begin, the new CRC must complete protocol-specific training, obtain a current GCP certificate, and be formally added to the Delegation of Authority Log by the PI with the specific tasks they are authorised to perform. Only after all three are in place can they begin trial work. DThey can shadow an existing CRC for the first month and take over tasks gradually without any documentationShadowing an existing team member observationally is acceptable before onboarding, but performing actual trial tasks requires full delegation. Observation is not a substitute for formal training and DoA Log entry. Previous Next Q 05 A team member leaves the site and their tasks need to be covered. What is the correct GCP process? AAsk another existing team member to cover informally until a replacement is foundAsking another team member to cover informally without updating the DoA Log means those tasks are now being performed by someone who is not formally delegated. This is a documentation gap that would be flagged at a monitoring visit. BSuspend all participant activities until a replacement is formally hiredSuspending participant activities is a significant step that should only be taken when no qualified coverage can be arranged at all. In most cases, an existing qualified team member can be formally delegated to cover, which is preferable to suspending trial activities. CThe PI must update the DoA Log to remove the departing team member and formally delegate their tasks to a qualified replacement or existing team member before those tasks continueCorrect. The departing team member's tasks must be formally reassigned. The DoA Log must be updated to remove the departing person and add the covering team member. If a new person is hired, they must complete training before being added. The PI signs all updates to the delegation log. DNotify the sponsor and let them update the delegation log remotelyThe sponsor cannot update the site's Delegation of Authority Log. The DoA Log is a site document maintained by the PI. The sponsor can request updates and the CRA can flag gaps, but the actual updates must come from the PI. Previous Finish Quiz 0 / 5 Try Again

Key Takeaways

1 GCP defines qualifications and responsibilities, not job titles. What matters is whether a person is qualified for a task and whether that task is properly documented on the Delegation of Authority Log. 2 Medical judgment cannot be delegated to non-clinical staff. SAE causality assessment, eligibility determination, and consent discussions require a medically qualified person. A CRC or data manager cannot perform these tasks regardless of experience. 3 No one performs a trial task before they are on the DoA Log. This is an absolute rule. Even a highly qualified sub-investigator cannot perform trial procedures without a current delegation entry signed by the PI. 4 Team changes must trigger immediate DoA Log updates. When someone joins or leaves the team, the delegation log must be updated before any change in who performs what tasks. There is no grace period. 5 The pharmacist cannot dispense without a valid prescription from an authorised delegated prescriber. This is both a GCP requirement and a professional pharmacy obligation. IP dispensing on an unauthorised instruction is a critical deviation. [tcb-script]/* ROLE TABS */function showRole(code){ document.querySelectorAll('.role-tab').forEach(function(t){ t.classList.remove('active'); }); document.querySelectorAll('.role-panel').forEach(function(p){ p.classList.remove('active'); }); event.target.classList.add('active'); document.getElementById('rp-'+code).classList.add('active');}/* ASSIGN ACTIVITY */var ASSIGN = [ { task:'Conduct a participant eligibility assessment and confirm they meet all inclusion criteria', answer:'Sub-Investigator', fb:'Eligibility assessment requires a medically qualified person. This must be performed by the PI or a delegated sub-investigator.' }, { task:'File the latest monitoring visit report in the correct ISF zone', answer:'CRC', fb:'ISF management is a core CRC responsibility. This administrative task does not require clinical qualification.' }, { task:'Draw blood samples for the protocol-required pharmacokinetic assessment', answer:'Research Nurse', fb:'Clinical procedures such as blood draws are within the research nurse's scope when properly trained and delegated.' }, { task:'Receive a new shipment of investigational product and update the IP accountability log', answer:'Trial Pharmacist', fb:'IP receipt, storage, and accountability log management are core pharmacist responsibilities in a clinical trial.' }, { task:'Assess whether a reported headache meets the protocol definition of a serious adverse event', answer:'Sub-Investigator', fb:'SAE assessment requires medical judgment. Only the PI or a medically qualified sub-investigator can perform this assessment.' }, { task:'Enter participant laboratory results into the electronic CRF', answer:'CRC', fb:'CRF data entry is a CRC task. The PI ensures accuracy and reviews key data, but routine entry is delegatable to the CRC.' }, { task:'Respond to a data query from the sponsor about a missing visit date', answer:'CRC', fb:'Data query resolution for administrative and logistical fields is a CRC responsibility. Queries about clinical findings should be escalated to the PI.' }, { task:'Dispense the investigational product to a participant following the randomisation schedule', answer:'Trial Pharmacist', fb:'IP dispensing is the pharmacist's responsibility, performed on the authority of a valid prescription from the PI or delegated sub-investigator.' }];(function buildAssign(){ var opts = ['Sub-Investigator','CRC','Research Nurse','Trial Pharmacist']; var html = ''; ASSIGN.forEach(function(a,i){ var optsHtml = '<option value="">-- Select --</option>' + opts.map(function(o){ return '<option>'+o+'</option>'; }).join(''); html += '<div>' + '<div>'+a.task+'</div>' + '<select id="as-'+i+'">'+optsHtml+'</select>' + '<div id="af-'+i+'"></div>' + '</div>'; }); document.getElementById('assign-list').innerHTML = html;})();function checkAssign(){ var correct = 0; ASSIGN.forEach(function(a,i){ var sel = document.getElementById('as-'+i); var fb = document.getElementById('af-'+i); var val = sel.value; sel.style.pointerEvents = 'none'; if(!val || val==='-- Select --'){ sel.className='assign-select fail'; fb.innerHTML='Please select an answer.'; fb.className='assign-fb show fail'; return; } if(val===a.answer){ correct++; sel.className='assign-select ok'; fb.innerHTML='<strong>Correct.</strong> '+a.fb; fb.className='assign-fb show ok'; } else { sel.className='assign-select fail'; fb.innerHTML='<strong>Not quite.</strong> '+a.fb+' The correct answer is: <strong>'+a.answer+'</strong>.'; fb.className='assign-fb show fail'; } }); document.getElementById('assign-result').classList.add('show'); document.getElementById('assign-score').innerHTML = correct+'<span>/'+ASSIGN.length+'</span>'; var msgs=['Review the role definitions above.','A few roles to revisit.','Good understanding with some gaps.','Almost perfect.','Excellent.','','','','Perfect score.']; document.getElementById('assign-msg').textContent = msgs[correct] || 'Great result.';}/* COMM SCENARIOS */var COMMS = [ { label:'Scenario 1 of 5', text:'A participant calls the site and tells the CRC that they have been experiencing severe abdominal pain for two days. The CRC is not sure if this is serious enough to be an SAE.', opts:[ 'The CRC should document the call and wait to see if the pain resolves before involving the PI', 'The CRC should immediately notify the PI or on-call sub-investigator who will assess the event and determine whether it meets SAE criteria', 'The CRC should tell the participant to go to any hospital and not involve the PI unless the participant is admitted' ], correct:1, ok:'Correct. SAE assessment must involve a medically qualified person. The CRC's role is to document the report and escalate immediately to the PI. Any delay in escalation could result in a missed reporting deadline.', fail:'Not correct. The CRC cannot independently determine whether an event is an SAE. That requires medical judgment. The PI or sub-investigator must be notified immediately so they can assess the event within the required reporting timeline.' }, { label:'Scenario 2 of 5', text:'The CRC notices that a source document has an error: the date of a participant visit was recorded as the 14th when the visit actually occurred on the 15th. The PI is in clinic. What should the CRC do?', opts:[ 'Correct the error themselves by crossing out the wrong date, writing the correct date, and initialling it', 'Leave the error and note it in an email to the PI to address when available', 'Flag the error to the PI as soon as possible so the PI can make the correction using the correct GCP method: single line, correct value, date, signature, and reason if needed' ], correct:2, ok:'Correct. Source document corrections must follow the GCP standard: a single line through the error, the correct value written clearly, the date of correction, and the signature of the person making the correction. Whether the CRC or PI makes the correction depends on who made the original entry and their delegation. The key point is that the correction method must be correct.', fail:'Not correct. While a CRC can make corrections to documents within their delegated scope, the method matters. A correction cannot obscure the original entry. It must be a single line through, with the correct value, date, and signature. Leaving errors uncorrected or making them informally is also wrong.' }, { label:'Scenario 3 of 5', text:'The trial pharmacist receives a call from a participant asking whether they can take a specific over-the-counter painkiller alongside their investigational product. How should the pharmacist respond?', opts:[ 'Advise the participant based on their professional pharmaceutical knowledge', 'Tell the participant the combination is safe without checking the protocol', 'Tell the participant they need to ask the PI or sub-investigator, as concomitant medication decisions must be made by the delegated clinician in the context of the trial protocol' ], correct:2, ok:'Correct. Concomitant medication decisions in a clinical trial are clinical decisions that must be made by the PI or delegated sub-investigator with reference to the protocol. The pharmacist supports the clinical decision but cannot make it independently for trial participants.', fail:'Not correct. Even a pharmacist with strong knowledge of drug interactions must defer concomitant medication decisions in a clinical trial to the PI or delegated sub-investigator. The protocol may restrict specific medications, and the PI is accountable for those decisions.' }, { label:'Scenario 4 of 5', text:'A sub-investigator disagrees with the PI's decision to keep a participant enrolled despite a borderline eligibility issue. The sub-investigator believes the participant should be withdrawn. What is the appropriate action?', opts:[ 'The sub-investigator should withdraw the participant independently based on their own clinical assessment', 'The sub-investigator should raise their concern directly with the PI, document the discussion, and if the disagreement is serious, escalate to the sponsor or ethics committee through appropriate channels', 'The sub-investigator should say nothing and follow the PI's decision without comment' ], correct:1, ok:'Correct. Professional disagreement should be raised directly with the PI and documented. If the concern involves a potential safety issue and the PI does not respond appropriately, the sub-investigator has an obligation to escalate through the sponsor or ethics committee. Unilateral action by the sub-investigator that overrides the PI is not the right first step.', fail:'Not correct. Both ignoring the concern and acting unilaterally are problematic. The correct approach is professional communication with the PI, documentation of the discussion, and formal escalation if the concern involves participant safety and is not adequately addressed.' }, { label:'Scenario 5 of 5', text:'The CRC realises that a monitoring visit is scheduled for next week and the ISF has three missing documents that should have been filed months ago. The PI is aware. What should the team do?', opts:[ 'Create the missing documents retroactively using approximate dates so the ISF looks complete', 'Contact the relevant parties immediately to obtain legitimate original documents where possible, document what is missing and why, and be prepared to explain the gaps honestly to the CRA during the visit', 'Remove any reference to the missing documents from the ISF table of contents so the CRA does not notice' ], correct:1, ok:'Correct. The team should make every effort to obtain legitimate originals before the visit. What they must never do is create false documents or conceal gaps. If gaps remain, they must be acknowledged honestly. A missing document is a finding; a fabricated document is a critical violation.', fail:'Not correct. Creating documents with approximate dates is fabrication, and removing references to missing items is concealment. Both are far more serious than the original gap. The correct approach is transparency, legitimate remediation where possible, and honest acknowledgment of any remaining gaps.' }];var commCur=0, commScore=0, commAnswered=false;function renderComm(){ if(commCur>=COMMS.length){ document.getElementById('comm-content').innerHTML= '<div style="text-align:center;padding:12px 0;">'+ '<div style="font-size:42px;font-weight:800;color:var(--navy-dark);margin-bottom:5px;">'+commScore+'<span style="font-size:22px;color:var(--navy);"> / '+COMMS.length+'</span></div>'+ '<div style="font-size:13.5px;color:var(--soft);">'+(commScore>=4?'Strong team communication and escalation knowledge.':'Review the scenarios above and the role boundaries.')+'</div>'+ '</div>'; return; } var c=COMMS[commCur]; var optsHtml=c.opts.map(function(o,i){ return '<button onclick="answerComm('+i+')">'+o+'</button>'; }).join(''); document.getElementById('comm-content').innerHTML= '<div>'+c.label+' | Score: '+commScore+'</div>'+ '<div><div>Situation</div><div>'+c.text+'</div></div>'+ '<div>'+optsHtml+'</div>'+ '<div id="comm-fb"></div>'; commAnswered=false;}function answerComm(i){ if(commAnswered) return; commAnswered=true; var c=COMMS[commCur]; var btns=document.querySelectorAll('.comm-opt'); btns.forEach(function(b){ b.classList.add('locked'); }); var ok=i===c.correct; btns[i].classList.add(ok?'correct':'wrong'); if(!ok) btns[c.correct].classList.add('correct'); if(ok) commScore++; var fb=document.getElementById('comm-fb'); fb.className='comm-fb show '+(ok?'ok':'fail'); fb.innerHTML='<strong>'+(ok?'Correct.':'Not correct.')+'</strong> '+(ok?c.ok:c.fail); var btn=document.createElement('button'); btn.className='btn-comm-next'; btn.textContent=commCur<COMMS.length-1?'Next Scenario u2192':'See Results'; btn.onclick=function(){ commCur++; renderComm(); }; fb.appendChild(btn);}renderComm();/* QUIZ */var cur=1,score=0,done={},total=5;var msgs=['Review team roles and try again.','A few areas to revisit.','Solid understanding.','Almost perfect.','Excellent.','Perfect score.'];function pick(el,correct){ if(done[cur]) return; done[cur]=true; var all=el.closest('.opts').querySelectorAll('.opt'); all.forEach(function(o){ o.classList.add('locked'); }); if(correct){ el.classList.add('correct'); score++; document.getElementById('q-score').textContent='Score: '+score; } else{ el.classList.add('wrong'); all.forEach(function(o){ if(!o.classList.contains('wrong')){ var f=o.querySelector('.opt-fb'); if(f&&f.textContent.indexOf('Correct')===0) o.classList.add('correct'); } }); } var nb=document.getElementById('nb-'+cur); if(nb) nb.disabled=false; document.getElementById('prog-fill').style.width=((Object.keys(done).length/total)*100)+'%';}function nextQ(f){ document.getElementById('qb-'+f).classList.remove('active'); document.getElementById('qb-'+(f+1)).classList.add('active'); cur=f+1; document.getElementById('q-counter').textContent='Question '+cur+' of '+total; }function prevQ(f){ document.getElementById('qb-'+f).classList.remove('active'); document.getElementById('qb-'+(f-1)).classList.add('active'); cur=f-1; document.getElementById('q-counter').textContent='Question '+cur+' of '+total; }function finishQ(){ document.getElementById('qb-5').classList.remove('active'); document.getElementById('q-result').classList.add('show'); document.getElementById('res-score').innerHTML=score+'<span> / 5</span>'; document.getElementById('res-msg').textContent=msgs[score]; document.getElementById('prog-fill').style.width='100%'; document.getElementById('q-counter').textContent='Complete'; }function retryQ(){ score=0; cur=1; done={}; for(var i=1;i<=total;i++){ var b=document.getElementById('qb-'+i); b.querySelectorAll('.opt').forEach(function(o){ o.className='opt'; }); b.classList.remove('active'); var nb=document.getElementById('nb-'+i); if(nb) nb.disabled=true; } document.getElementById('qb-1').classList.add('active'); document.getElementById('q-result').classList.remove('show'); document.getElementById('q-score').textContent='Score: 0'; document.getElementById('q-counter').textContent='Question 1 of 5'; document.getElementById('prog-fill').style.width='0%';}[/tcb-script]

3.2 The Site Team: Delegation and Roles

You must be logged in to access this course