Lesson 3.3 — The Delegation of Authority Log Chapter 3 Lesson 3 30 min Interactive + Quiz Introduction

The Delegation of Authority Log

The Delegation of Authority Log, often called the DoA Log or simply the delegation log, is the document that formally records who is authorised to perform which tasks in a clinical trial. It is one of the most frequently reviewed documents at a monitoring visit, and errors or gaps in the DoA Log are among the most common findings in GCP inspections.

The DoA Log translates the organisational structure of the site team into a GCP-compliant record. Every task that is performed by someone other than the PI must be traceable back to an entry on this log. Without it, there is no documented basis for that person's involvement in the trial.

If someone performs a trial task and they are not on the DoA Log for that task, the task has no documented authorisation under GCP. The person may be fully qualified. The task may have been performed correctly. But without the delegation entry, it did not happen in a GCP-compliant way.

Part 1

Anatomy of a DoA Log Entry

Every DoA Log entry must contain specific information to be valid. Click any row in the example log below to see what each field means and why it is required.

Click a row to expand the details.

Name and Role Delegated Tasks Start Date End Date PI Signature Dr. Layla Mansour, Sub-Investigator Eligibility, consent, AE assessment 12 Jan 2024 Ongoing Signed Name and RoleDr. Layla Mansour, Sub-Investigator Start Date12 Jan 2024 End DateOngoing (no end date assigned yet) Delegated TasksEligibility assessment, informed consent discussion, adverse event causality assessment

Why this matters: Dr. Mansour's entry establishes that she is authorised to perform medical tasks from 12 Jan 2024. Any adverse event assessment she performs before that date would have no delegation basis. The specific task list means she is only authorised for the listed tasks; if she later needs to perform a task not listed here, the PI must update the log.

Ms. Nadia Al-Rashid, CRC ISF management, CRF entry, visit scheduling 12 Jan 2024 Ongoing Signed Name and RoleMs. Nadia Al-Rashid, Clinical Research Coordinator Start Date12 Jan 2024 End DateOngoing Delegated TasksISF management, CRF data entry, participant visit scheduling

Why this matters: Ms. Al-Rashid's tasks are administrative and do not include clinical activities. Her delegation is clear and limited to what a CRC can appropriately do. If she were also trained to administer questionnaires or collect patient-reported outcomes, those tasks would need to be added explicitly.

Mr. Khalid Nasser, Pharmacist IP receipt, storage, dispensing, accountability 12 Jan 2024 Ongoing Signed Name and RoleMr. Khalid Nasser, Trial Pharmacist Start Date12 Jan 2024 End DateOngoing Delegated TasksIP receipt, temperature-controlled storage, dispensing per randomisation schedule, accountability log management, return and destruction coordination

Why this matters: The pharmacist entry establishes the formal basis for IP management at the site. Without this entry, any IP dispensing activity would be unauthorised under GCP. The tasks are comprehensive and cover the full IP management cycle so no gap in authority exists.

Ms. Hana Yousef, Research Nurse Vital signs, blood draws, ECG, sample processing 03 Mar 2024 Ongoing Signed Name and RoleMs. Hana Yousef, Research Nurse Start Date03 Mar 2024 End DateOngoing Delegated TasksVital sign measurement, venepuncture and blood sample collection, ECG recording, sample labelling and processing

Why this matters: Ms. Yousef joined the team two months after trial start. Her start date of 03 Mar means any nursing tasks she performed before that date were undelegated. If a monitoring visit finds nursing procedures in source documents dated before 03 Mar attributed to her, that is a finding. The precise start date is critical.

Dr. Omar Faris, Sub-Investigator Eligibility, consent, AE assessment 01 May 2024 31 Aug 2024 Signed Name and RoleDr. Omar Faris, Sub-Investigator Start Date01 May 2024 End Date31 Aug 2024 (departed the site) Delegated TasksEligibility assessment, informed consent, adverse event causality assessment

Why this matters: Dr. Faris has a closed end date, meaning he left the site. This entry correctly documents both when his delegation began and when it ended. Any activity by Dr. Faris after 31 Aug 2024 would be undelegated. The closed end date also protects the site: it makes clear that current activities are not his responsibility.

Common DoA Log error seen in Arab country sites: The PI signs the DoA Log once at the start of the trial and never updates it when team members change. By the end of a two-year trial, three people have joined, two have left, and one person's tasks have changed significantly, but the DoA Log still shows only the original team. Every change requires a contemporaneous update signed by the PI.

Part 2

Fix the DoA Log Finding

During monitoring visits, CRAs often find errors in the DoA Log. For each finding below, identify the correct remediation action. Work through three sequential findings.

Activity: Remediate the Finding

The CRA has identified three DoA Log findings at your site. For each one, select the correct remediation action from the options provided.

Part 3

When Must the DoA Log Be Updated?

The DoA Log is a living document. It must be updated any time there is a change in who is doing what at the site. Understanding exactly when an update is required is a critical operational skill.

Updates are required when: a new team member joins and needs to perform trial tasks; a team member leaves or is removed from the trial; an existing team member takes on new tasks not previously delegated; a team member's GCP certificate expires and is renewed; a task is removed from someone's delegation; or the PI changes.

Updates are not required for: administrative changes that do not affect delegated tasks; changes to a team member's personal details that do not affect their role; or internal reporting line changes that do not change what tasks are performed.

✓

Knowledge Check

Question 1 of 5 Score: 0 Q 01 A CRA reviews the DoA Log and finds that a research nurse performed vital sign measurements for six visits before her start date was added to the log. How should this be classified? ANot a finding, because the nurse is medically qualified and GCP does not apply to nursing proceduresVital sign measurements are trial procedures that require delegation. Performing them before the delegation entry exists means those measurements were not properly authorised, regardless of the nurse's clinical competence. BA protocol deviation, because trial procedures were performed without a valid delegation entry in the DoA LogCorrect. Performing trial procedures without a DoA Log entry is an undelegated activity, which is a protocol deviation. The start date on the delegation log defines when the nurse's authority to perform those tasks began. All activity before that date is undelegated and should be documented as a deviation. CNot a finding if the vital sign measurements themselves appear accurate in the source documentsWhether the data is accurate is a separate question. The GCP issue is that the person performing the task had no documented authorisation when she performed it. Data accuracy does not resolve an authorisation gap. DNot a finding if the CRA approves the six visits retrospectively during the monitoring visitThe CRA cannot retroactively approve undelegated activity. The correct response is to acknowledge the deviation, document it, and put measures in place to prevent it from happening again. The CRA's role is to identify and report findings, not to approve past non-compliance. Previous Next Q 02 The PI signs the DoA Log on behalf of a sub-investigator who is away at a conference to meet a submission deadline. Is this acceptable? AYes, if the deadline is urgent and the sub-investigator gave verbal permissionThere is no acceptable time pressure justification for signing on behalf of another person. The signature on the DoA Log must be the person's own. The PI signing for the sub-investigator creates a false record. BYes, if the CRA witnesses the PI signing and notes it in the monitoring reportThe CRA is not a notary and cannot certify proxy signatures for GCP documents. This does not resolve the signature falsification issue. CNo. Each person must sign personally. The submission should wait until the sub-investigator can sign, or an electronic option should be used if available.Correct. Each person must sign the DoA Log personally. The PI signing on behalf of a sub-investigator creates a false record, which is a data integrity violation. The correct approach is to wait for the sub-investigator to return and sign personally, or to complete the process electronically if the system supports remote signing. DYes, as long as the PI notes the reason for signing on the sub-investigator's behalf in the remarks columnNoting the reason in the remarks column does not make a proxy signature acceptable. A note explaining why someone else signed does not transform a false signature into a valid one. Previous Next Q 03 A sub-investigator's GCP certificate expires during the trial. She completes renewal training the following week. What must happen before she continues performing delegated tasks? AShe can continue performing tasks during the gap because her medical degree still qualifies herContinuing tasks during the gap between expiry and renewal means performing delegated tasks with an invalid qualification. The training record is part of the qualification basis. Even a short gap is a compliance finding. BShe can continue if the PI verbally confirms she is still qualifiedVerbal confirmation from the PI that she is still qualified does not substitute for a valid GCP certificate. The certificate is a documented requirement that cannot be waived verbally. CThe renewed GCP certificate must be filed in the ISF. She should not have performed tasks during the expiry gap, and the DoA Log should be reviewed to confirm her continued delegation is properly supported.Correct. The new GCP certificate must be filed in the ISF and the DoA Log must be reviewed to confirm her tasks remain valid. She should not perform delegated tasks during the gap between expiry and renewal, and any tasks performed during the gap should be investigated and documented as a potential deviation. DThe sub-investigator must be removed from the DoA Log and re-added from scratch with a new entry dateThe DoA Log does not need to be rewritten from scratch for a certificate renewal. The existing entry is valid; the updated certificate is the supporting document. However, the PI should review and confirm the entry is still current, and the certificate must be filed. Previous Next Q 04 What is the purpose of recording an end date for a team member on the DoA Log? AIt is an HR requirement that has no specific GCP significanceEnd dates are not primarily for HR purposes. The DoA Log is a GCP document that defines the scope and duration of authorised activity in the trial. Its purpose is clinical operations compliance, not employment administration. BIt formally closes the person's delegation, making clear that any activity after that date was not authorised and that responsibility has been formally transferredCorrect. The end date formally closes a person's delegation. It establishes clearly that any trial activity attributed to that person after the end date was not authorised, and that their responsibilities were formally transferred or ended. This is critical for audit trail clarity and for protecting both the site and the departing team member. CIt triggers payment for that team member's work up to that dateEnd dates do not affect payment schedules. The DoA Log is a clinical compliance document, not a financial one. DIt is only needed when the team member was involved in an SAE during their time on the trialEnd dates are required for all departing team members, not only those involved in SAEs. The end date documents the close of delegation for any reason. Previous Next Q 05 The PI is replaced mid-trial by a new PI. What must happen to the DoA Log? ANothing, the existing DoA Log carries over automatically to the new PIA new PI cannot simply inherit the existing DoA Log without any action. The new PI must personally review the delegation structure, confirm they accept accountability for the existing delegations, and sign the log to establish their own documented authority from the transition date. BThe existing DoA Log should be destroyed and a completely new one created from the transition dateDestroying the existing log would destroy critical historical documentation. All prior delegation records must be retained. A new section or updated log is created, but the historical record is preserved. CThe outgoing PI's end date must be recorded, the new PI must be entered with a start date and must personally sign the log to assume accountability. The sponsor must also be notified of the PI change.Correct. The outgoing PI's end date must be recorded. The new PI must be formally entered with their start date and must personally sign to document their assumption of the PI role and their acknowledgment of the existing delegation structure. The sponsor must also be notified of the PI change. DOnly the DoA Log needs updating; the sponsor does not need to be informed of a PI changeThe sponsor must be notified of a PI change as it is a significant site-level event that affects the trial's regulatory standing. The DoA Log update and sponsor notification are both required. Previous Finish Quiz 0 / 5 Try Again

Key Takeaways

1 The DoA Log is the documented basis for every delegated trial task. If a task is not on the log for that person, it has no authorisation under GCP, regardless of whether it was performed correctly. 2 Start dates must precede any delegated activity. A person cannot perform trial tasks before their entry date. Any mismatch between their DoA Log start date and actual task dates is a protocol deviation. 3 End dates must be recorded when a team member leaves. A closed delegation entry provides a clear audit trail and protects both the site and the departing person from being associated with activity that occurred after their departure. 4 Every person signs their own entry. Proxy signatures on the DoA Log are not acceptable. Each team member must sign personally to confirm they understand and accept their delegated responsibilities. 5 The DoA Log must be updated contemporaneously. Every team change, task change, or role change must be reflected in the log at the time it occurs, not weeks later during a monitoring visit preparation sprint. [tcb-script]/* LOG ROW TOGGLE */function toggleLogRow(n){ var detail = document.getElementById('ld-'+n); var wasOpen = detail.classList.contains('show'); document.querySelectorAll('.log-detail').forEach(function(d){ d.classList.remove('show'); }); document.querySelectorAll('.log-row').forEach(function(r){ r.classList.remove('active'); }); if(!wasOpen){ detail.classList.add('show'); detail.previousElementSibling.classList.add('active'); }}/* BUILDER / REMEDIATE ACTIVITY */var FINDINGS = [ { finding: 'Finding 1: The DoA Log shows that Dr. Hana Al-Said performed adverse event causality assessments on three participants. However, "adverse event causality assessment" is not listed among her delegated tasks on the DoA Log.', fields:[ { label:'What is the correct remediation?', options:['-- Select --','Ask Dr. Hana to add the task to her own entry retroactively','The PI must formally update the DoA Log to add this task to Dr. Hana's delegation, with the correct date from which she is authorised to perform it','Remove all three AE assessments from the records and have another team member redo them'], answer:"The PI must formally update the DoA Log to add this task to Dr. Hana's delegation, with the correct date from which she is authorised to perform it", ok:'Correct. Only the PI can update the DoA Log. The PI must add the task with an appropriate start date. The three assessments already performed will need to be flagged as a deviation and documented with a CAPA explaining how task scope was not properly documented at the time.', fail:'Not correct. Team members cannot update their own DoA Log entries. Only the PI can make additions. Removing the assessments from the record would also destroy valid clinical data. The PI must make a formal, dated amendment to the log.' } ] }, { finding: 'Finding 2: The DoA Log has no end date recorded for a CRC who left the site eight months ago. Source documents show no activity by that person after they left, but the log entry remains open.', fields:[ { label:'What is the correct remediation?', options:['-- Select --','Leave the log as it is since no activities occurred after departure','The PI must add the departure date as the end date on the CRC's entry, signed and dated by the PI with today's date and a note explaining the retrospective update','Delete the CRC's entry from the DoA Log entirely'], answer:"The PI must add the departure date as the end date on the CRC's entry, signed and dated by the PI with today's date and a note explaining the retrospective update", ok:'Correct. The PI must close the delegation entry by adding the end date. Since this is a retrospective correction, the PI should add today's date as the correction date and note that the update reflects the actual departure date, following the standard GCP correction method.', fail:'Not correct. Leaving the entry open is a documentation gap, and deleting it would destroy the audit trail. The correct action is to close the entry properly with the departure date and document that this is a retrospective update.' } ] }, { finding: 'Finding 3: A newly joined sub-investigator signed the DoA Log with a date of 01 October, but source documents show she performed an eligibility assessment on 28 September, three days before her DoA Log entry.', fields:[ { label:'What is the correct remediation?', options:['-- Select --','Change the DoA Log start date to 28 September to make the log consistent with the source documents','Document the three-day period as a protocol deviation, complete a root cause analysis, and implement a CAPA to prevent future undelegated activity','Ask the sub-investigator to add a note in the source documents explaining she was verbally authorised before 01 October'], answer:'Document the three-day period as a protocol deviation, complete a root cause analysis, and implement a CAPA to prevent future undelegated activity', ok:'Correct. The undelegated eligibility assessment is a protocol deviation. It must be formally documented. Changing the DoA Log date to match the source documents would be backdating, which is worse than the original finding. The site must acknowledge the deviation honestly and prevent it from recurring.', fail:'Not correct. Backdating the DoA Log is a data integrity violation more serious than the original finding. Adding a verbal authorisation note does not substitute for documented delegation. The only acceptable response is to acknowledge the deviation, document it properly, and implement preventive measures.' } ] }];var bCur=0, bFieldIdx=0, bScore=0, bTotal=0;function renderBuilder(){ if(bCur>=FINDINGS.length){ document.getElementById('builder-content').innerHTML= '<div style="text-align:center;padding:14px 0;">'+ '<div style="font-size:40px;font-weight:800;color:var(--navy-dark);margin-bottom:5px;">'+bScore+'<span style="font-size:22px;color:var(--navy);"> / '+bTotal+'</span></div>'+ '<div style="font-size:13.5px;color:var(--soft);">'+(bScore>=bTotal-1?'Excellent DoA Log remediation skills.':'Review the correct answers above and the DoA Log anatomy section.')+'</div>'+ '</div>'; return; } var f=FINDINGS[bCur]; var fld=f.fields[bFieldIdx]; var optsHtml=fld.options.map(function(o){ return '<option'+(o==='-- Select --'?' disabled selected':'')+'>'+o+'</option>'; }).join(''); document.getElementById('builder-content').innerHTML= '<div style="font-size:11px;font-weight:700;letter-spacing:1px;text-transform:uppercase;color:var(--navy);margin-bottom:10px;">Finding '+(bCur+1)+' of '+FINDINGS.length+'</div>'+ '<div><div>CRA Finding</div><div>'+f.finding+'</div></div>'+ '<div><label>'+fld.label+'</label>'+ '<select id="bsel">'+optsHtml+'</select></div>'+ '<button onclick="checkBuilder()">Check Answer</button>'+ '<div id="builder-res"></div>'; bTotal++;}function checkBuilder(){ var fld=FINDINGS[bCur].fields[bFieldIdx]; var sel=document.getElementById('bsel'); var res=document.getElementById('builder-res'); var val=sel.value; if(!val||val==='-- Select --'){ res.className='builder-result show builder-fail'; res.textContent='Please select an option.'; return; } sel.style.pointerEvents='none'; document.querySelector('.btn-builder-check').style.display='none'; var ok=val===fld.answer; if(ok){ sel.className='builder-select ok'; res.className='builder-result show builder-ok'; res.innerHTML='<strong>Correct.</strong> '+fld.ok; bScore++; } else { sel.className='builder-select fail'; res.className='builder-result show builder-fail'; res.innerHTML='<strong>Not quite.</strong> '+fld.fail+'<br><em>Correct answer: '+fld.answer+'</em>'; } var btn=document.createElement('button'); var isLast=(bFieldIdx===FINDINGS[bCur].fields.length-1); btn.className='btn-builder-next'; btn.textContent=isLast&&bCur<FINDINGS.length-1?'Next Finding u2192':isLast?'See Results':'Next Step u2192'; btn.onclick=function(){ if(bFieldIdx<FINDINGS[bCur].fields.length-1){ bFieldIdx++; } else { bCur++; bFieldIdx=0; } renderBuilder(); }; res.appendChild(btn);}renderBuilder();/* QUIZ */var cur=1,score=0,done={},total=5;var msgs=['Review the DoA Log concepts 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]

3.3 The Delegation of Authority Log

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