Map what counts as source, how it is captured and where authorised reviewers can retrieve it
A research source records location list should define the original records and data for each important trial activity, identify the capture method and controlled location, and keep changes traceable. English matters because “stored in the hospital system” is not precise enough when one participant journey can cross paper notes, devices, laboratories, pharmacies and electronic platforms.
Choose the route closest to your task, or read straight through for the complete system.
People search for a clinical trial source document location list, source data agreement and essential-record map because modern research rarely lives in one binder. A vital sign may begin on a device, flow to an electronic health record and then be transcribed or transferred to an electronic case report form.
A useful list identifies the data or activity, source-record definition, capture method, system or physical repository, exact retrievable location, record owner, authorised access, metadata or audit trail, certified-copy route, retention responsibility and change history. It should be detailed enough for a competent reviewer to find evidence without publishing security-sensitive paths.
The central mechanism is provenance. The list explains where the first durable record is created, which later copies or transfers are derived, how changes are traced and who retains the authoritative record. “Source” is a defined role in the evidence chain, not simply the first screen someone remembers using.
This article is educational guidance checked on 11 October 2026. The protocol, data-management plan, source data agreement, sponsor and site procedures, system validation, contracts, privacy controls and applicable law govern a real trial.
Did You Know? Singapore HSA’s template-forms page, last updated 24 March 2026, includes a new Source Records Location List intended to define what counts as source records, the methods of data capture and their locations before a trial starts. HSA also says suitable alternatives may be used and templates may be customised, so the value lies in an accurate map of the real study—not in copying a generic form.
Find the section you need
Define the source · 2 chapters
Locate precisely · 2 chapters
Control access · 2 chapters
Manage change · 2 chapters
Retain and retrieve · 3 chapters
A location list can become a miscellaneous inventory unless its study, site, version and purpose are explicit.
State scope, owner, approval, effective date, connected plans and change-control route.
The list covers participant source records at one investigator site but references a separate sponsor system map.
What to check
- Name study
- Name site
- Name owner
- Control version
Trace one data element from observation through source, transfer, case-report entry and later correction.
Ask whether a system outage, staff change or site move would break retrieval.
Boundary: The real record architecture may require several coordinated maps.
Learning transfer: Scope supports research planning.
Write one sentence that states the evidence, one that states its limit, and one that states the next responsible action. Then test each noun, number, condition and source against the controlled document. Replace vague confidence with a traceable reason.
Folder-first mapping can miss records produced by conversations, devices or external services.
List consent, eligibility, visits, assessments, intervention, product, laboratory, imaging, safety and follow-up activities, then identify their source.
The consent discussion maps to the signed ICF and source note, while dosing maps to pharmacy and administration records.
What to check
- List activity
- Name data
- Name source
- Check owner
Write the location so an authorised reviewer can retrieve the record without exposing credentials or unnecessary security details.
Check whether metadata and audit trails remain linked to the content after export or certified copying.
Boundary: The protocol and process determine which activities matter.
Learning transfer: Classification supports science.
Write one sentence that states the evidence, one that states its limit, and one that states the next responsible action. Then test each noun, number, condition and source against the controlled document. Replace vague confidence with a traceable reason.
A value may be displayed temporarily before it is saved in an authoritative system.
Describe where the observation is first recorded durably, how date, time and author are attached, and whether later entry is transcription or direct capture.
A device reading becomes durable in the validated device file before selected values transfer to the clinical system.
What to check
- Find first record
- Check persistence
- Name author/time
- Mark transfer
Name who owns the record and who can authorise access, amendment, migration and archiving.
Confirm that the map reflects actual practice rather than an intended workflow that staff do not use.
Boundary: Technical validation and study definitions control the source role.
Learning transfer: Provenance supports digital literacy.
Write one sentence that states the evidence, one that states its limit, and one that states the next responsible action. Then test each noun, number, condition and source against the controlled document. Replace vague confidence with a traceable reason.
Paper, electronic, direct data capture, scanned image and hybrid workflow create different controls.
Record instrument or form, manual or automatic entry, contemporaneous timing, identifier, metadata and correction method.
A paper worksheet is signed contemporaneously and later certified as a true copy under procedure.
What to check
- Name medium
- Name method
- Check timing
- Explain correction
Trace one data element from observation through source, transfer, case-report entry and later correction.
Ask whether a system outage, staff change or site move would break retrieval.
Boundary: A scan is not automatically a certified copy.
Learning transfer: Method language supports experiments.
Write one sentence that states the evidence, one that states its limit, and one that states the next responsible action. Then test each noun, number, condition and source against the controlled document. Replace vague confidence with a traceable reason.
“EHR” or “site file” is too broad for efficient monitoring or inspection.
Name institution or owner, system or binder, module or section, record type and stable locator without exposing passwords or security-sensitive infrastructure.
The entry identifies the hospital EHR, laboratory-results module and participant encounter rather than only “online”.
What to check
- Name repository
- Name module
- Use stable locator
- Protect security
Write the location so an authorised reviewer can retrieve the record without exposing credentials or unnecessary security details.
Check whether metadata and audit trails remain linked to the content after export or certified copying.
Boundary: Authorised staff should test the path under actual permissions.
Learning transfer: Precise directions support life skills.
Write one sentence that states the evidence, one that states its limit, and one that states the next responsible action. Then test each noun, number, condition and source against the controlled document. Replace vague confidence with a traceable reason.
The person who enters data may not own the system or authorise external review.
Distinguish record generator, custodian, system owner, site responsibility, access approver and reviewer role.
The hospital owns the EHR; the PI retains study responsibility and arranges authorised direct access for monitoring.
What to check
- Name generator
- Name custodian
- Name approver
- Name reviewer
Name who owns the record and who can authorise access, amendment, migration and archiving.
Confirm that the map reflects actual practice rather than an intended workflow that staff do not use.
Boundary: Access must follow privacy, institutional and regulatory requirements.
Learning transfer: Responsibility language supports teamwork.
Write one sentence that states the evidence, one that states its limit, and one that states the next responsible action. Then test each noun, number, condition and source against the controlled document. Replace vague confidence with a traceable reason.
A case report form may contain data copied from source, calculated from several values or entered directly.
Mark source-to-destination flow, transformation, units, reconciliation and correction path.
A calculated renal measure cites the laboratory values and formula while the eCRF holds the derived result.
What to check
- Map origin
- Name transform
- Check units
- Trace correction
Trace one data element from observation through source, transfer, case-report entry and later correction.
Ask whether a system outage, staff change or site move would break retrieval.
Boundary: Do not label a derived value as the original observation.
Learning transfer: Data flow supports mathematics.
Write one sentence that states the evidence, one that states its limit, and one that states the next responsible action. Then test each noun, number, condition and source against the controlled document. Replace vague confidence with a traceable reason.
Laboratories, imaging vendors, home visits and participant devices may place records outside the main site.
Document contracts, transfer method, identifiers, data availability, metadata, access, failure handling and retention responsibility.
A central laboratory portal is mapped with report, transfer specification and site-access procedure.
What to check
- Name external party
- Name interface
- Check failure route
- Assign retention
Write the location so an authorised reviewer can retrieve the record without exposing credentials or unnecessary security details.
Check whether metadata and audit trails remain linked to the content after export or certified copying.
Boundary: Current agreements and applicable requirements control access and custody.
Learning transfer: Networks support technology learning.
Write one sentence that states the evidence, one that states its limit, and one that states the next responsible action. Then test each noun, number, condition and source against the controlled document. Replace vague confidence with a traceable reason.
Systems are replaced, departments move and paper records may be archived while a trial continues.
Record effective date, old and new location, migration validation, reconciliation, preserved metadata, approvals and retrieval test.
An EHR upgrade moves documents to an archive view; the team verifies participant links and audit history.
What to check
- Record change
- Preserve history
- Reconcile counts
- Test retrieval
Name who owns the record and who can authorise access, amendment, migration and archiving.
Confirm that the map reflects actual practice rather than an intended workflow that staff do not use.
Boundary: Never overwrite the historical map as though the old location never existed.
Learning transfer: Change logs support projects.
Write one sentence that states the evidence, one that states its limit, and one that states the next responsible action. Then test each noun, number, condition and source against the controlled document. Replace vague confidence with a traceable reason.
A responsible party may need a durable copy when a portal closes or another organisation retains the original.
Define when copies are made, how completeness and accuracy are verified, who certifies, what metadata travels and how access is protected.
Before vendor access ends, the site retains required exports with verification and controlled storage.
What to check
- Define trigger
- Verify copy
- Keep metadata
- Protect access
Trace one data element from observation through source, transfer, case-report entry and later correction.
Ask whether a system outage, staff change or site move would break retrieval.
Boundary: The responsible party who generated original essential records generally retains them, subject to applicable arrangements.
Learning transfer: Backup thinking supports digital safety.
Write one sentence that states the evidence, one that states its limit, and one that states the next responsible action. Then test each noun, number, condition and source against the controlled document. Replace vague confidence with a traceable reason.
11. Prepare for retention and close-out retrieval
Back to contentsA record that cannot be read or found years later has not been adequately preserved.
Name archival format, custodian, retention basis, access route, technology dependency, periodic readability check and change notification.
The close-out map records where source records remain, who can retrieve them and how future institutional changes will be communicated.
What to check
- Name custodian
- State basis
- Test readability
- Plan notification
Write the location so an authorised reviewer can retrieve the record without exposing credentials or unnecessary security details.
Check whether metadata and audit trails remain linked to the content after export or certified copying.
Boundary: Retention periods and responsibilities are jurisdiction- and product-specific; use current official requirements.
Learning transfer: Long-term thinking supports careers.
Write one sentence that states the evidence, one that states its limit, and one that states the next responsible action. Then test each noun, number, condition and source against the controlled document. Replace vague confidence with a traceable reason.
How to build this kind of English before the job title arrives
Back to contentsStudents do not need professional authority to practise the underlying language. They can learn to define scope, annotate conditions, compare versions, rebuild a timeline, match a number to its unit and explain uncertainty without embarrassment. Parents can ask calm questions: What decision is this document supporting? Which sentence carries the strongest claim? What would make that claim false? Which source would you open next?
Use a three-pass routine. First, map the document: title, owner, audience, date, sections and decision. Second, trace one claim from source to conclusion. Third, explain the limit and next action. This routine strengthens comprehension, science, mathematics, humanities and workplace readiness because it turns English into an evidence tool.
A student should never imitate professional authority. The useful goal is to recognise when a text needs a qualified reviewer, current rule or official decision. Knowing when to pause is part of literacy.
Observation
Sample collected under participant code and source procedure.
Creation
Laboratory instrument and validated system create the durable result with metadata.
Report
Authorised report becomes retrievable in the laboratory portal and site record.
Transfer
Specified fields move to the eCRF; reconciliation preserves differences and corrections.
Retention
Owner, certified-copy route, archive location and access after close-out are recorded.
Activity or data
What event, measure or decision is being documented.
Source definition
Which record is the first durable authoritative evidence.
Capture
Paper, electronic, device, direct or hybrid method.
Location
Repository, module, section and stable locator.
Governance
Owner, custodian, access approver and authorised reviewers.
Continuity
Change history, copy, retention and retrieval test.
Each case turns a fluent shortcut into an evidence, chronology, privacy or responsibility problem.
Case 1: Define what the list controls
The list covers participant source records at one investigator site but references a separate sponsor system map. Identify the tempting shortcut, check the controlled evidence, explain the consequence and draft a proportionate repair.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
Case 2: Describe the capture method
A paper worksheet is signed contemporaneously and later certified as a true copy under procedure. Identify the tempting shortcut, check the controlled evidence, explain the consequence and draft a proportionate repair.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
Case 3: Handle external, decentralised and device records
A central laboratory portal is mapped with report, transfer specification and site-access procedure. Identify the tempting shortcut, check the controlled evidence, explain the consequence and draft a proportionate repair.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
Case 4: Prepare for retention and close-out retrieval
The close-out map records where source records remain, who can retrieve them and how future institutional changes will be communicated. Identify the tempting shortcut, check the controlled evidence, explain the consequence and draft a proportionate repair.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
A parent, tutor, supervisor or peer may ask for the source and reasoning, but the learner should write the final evidence note independently.
Work with the current instruction and controlled evidence. Keep source wording, interpretation, consequence, decision, authority and version separate.
Define the source
Map data elements, activities and first durable records. Use Chapters 1–2 to build a dated evidence map and justify the next action.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
Locate precisely
Name repository, module, section and retrievable path. Use Chapters 3–4 to build a dated evidence map and justify the next action.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
Control access
Show owner, permissions, direct access and privacy. Use Chapters 5–6 to build a dated evidence map and justify the next action.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
Manage change
Track migrations, certified copies, devices and hybrid records. Use Chapters 7–8 to build a dated evidence map and justify the next action.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
Retain and retrieve
Plan close-out custody, readability and long-term availability. Use Chapters 9–10 to build a dated evidence map and justify the next action.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
Finish with three sentences: what the evidence supports, what remains uncertain and what authorised action comes next.
The underlying evidence should remain stable even when emphasis, detail and next action change with the reader.
Site lens
Real workflows and repositories must match the map.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
Data lens
Origin, transfer, transformation and correction need provenance.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
System lens
Metadata, permissions, validation and migration must endure.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
Reviewer lens
Authorised retrieval should be efficient and privacy-aware.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
Archivist lens
Custody, readability and access must survive close-out.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
Adaptation helps only when the shorter version preserves identity, source, status, rights, evidence, uncertainty and decision boundary.
Rebuild each decision chain, then compress it without losing the condition that controls the outcome.
Start with activities and data, not folders
Folder-first mapping can miss records produced by conversations, devices or external services. List consent, eligibility, visits, assessments, intervention, product, laboratory, imaging, safety and follow-up activities, then identify their source. Example: The consent discussion maps to the signed ICF and source note, while dosing maps to pharmacy and administration records. Test the source, audience, scope, date, authority, version and exception before accepting the conclusion.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
Identify the first durable record
A value may be displayed temporarily before it is saved in an authoritative system. Describe where the observation is first recorded durably, how date, time and author are attached, and whether later entry is transcription or direct capture. Example: A device reading becomes durable in the validated device file before selected values transfer to the clinical system. Test the source, audience, scope, date, authority, version and exception before accepting the conclusion.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
Specify a retrievable location
“EHR” or “site file” is too broad for efficient monitoring or inspection. Name institution or owner, system or binder, module or section, record type and stable locator without exposing passwords or security-sensitive infrastructure. Example: The entry identifies the hospital EHR, laboratory-results module and participant encounter rather than only “online”. Test the source, audience, scope, date, authority, version and exception before accepting the conclusion.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
Link derived records and transcription
A case report form may contain data copied from source, calculated from several values or entered directly. Mark source-to-destination flow, transformation, units, reconciliation and correction path. Example: A calculated renal measure cites the laboratory values and formula while the eCRF holds the derived result. Test the source, audience, scope, date, authority, version and exception before accepting the conclusion.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
Plan certified copies and contingencies
A responsible party may need a durable copy when a portal closes or another organisation retains the original. Define when copies are made, how completeness and accuracy are verified, who certifies, what metadata travels and how access is protected. Example: Before vendor access ends, the site retains required exports with verification and controlled storage. Test the source, audience, scope, date, authority, version and exception before accepting the conclusion.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
Repeat after a source, participant need, person, risk, permission, version or timetable changes.
A polished line can conceal a missing definition, identifier, version, right, permission or condition.
Source test
Identify the first durable record and distinguish later copies or transfers.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
Location test
Make retrieval possible without exposing credentials.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
Ownership test
Separate generator, custodian, system owner and access approver.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
Continuity test
Preserve metadata, history, migration and archival retrieval.
State the controlling source, approved version, people affected, date, evidence, decision authority and uncertainty. Then write the narrowest conclusion that remains accurate if the scope, participant need, system, instruction or timetable changes.
Keep the failed version beside the repair. The contrast shows exactly where language moved beyond authorised evidence.
Answer each prompt in a complete sentence tied to a current instruction, approved version, dated source, observation or authorised clarification. Write “unknown” where the record does not support an answer.
- Name study? Record the evidence and the conclusion it permits.
- Name site? Record the evidence and the conclusion it permits.
- Name owner? Record the evidence and the conclusion it permits.
- Control version? Record the evidence and the conclusion it permits.
- List activity? Record the evidence and the conclusion it permits.
- Name data? Record the evidence and the conclusion it permits.
- Name source? Record the evidence and the conclusion it permits.
- Check owner? Record the evidence and the conclusion it permits.
- Find first record? Record the evidence and the conclusion it permits.
- Check persistence? Record the evidence and the conclusion it permits.
- Name author/time? Record the evidence and the conclusion it permits.
- Mark transfer? Record the evidence and the conclusion it permits.
Independent-reader test
Give the working note to a careful reader who was not present. Ask them to identify the study, audience, source, approved version, reasoning, authority, uncertainty and next action without extra explanation.
Change test
Imagine the protocol, participant need, investigator, platform or approval condition changes tomorrow. Mark every sentence that would need revision.
Decision log
Keep the instruction consulted, date, choice, responsible person and reason. Add rejected alternatives when they may be revisited.
Parent or mentor conversation
Ask: Which words carry the strongest claim? What evidence controls those words? What condition would make you revise the conclusion?
What is a source records location list?
It is a controlled map of what counts as source, how it is captured and where it can be retrieved.
Does HSA require its exact template?
HSA says the templates assist trial conduct and suitable alternatives may be used; customise to the real study.
Is the eCRF always the source?
No. It may be source for direct data entry or a derived destination; define the actual evidence chain.
How precise should a location be?
Precise enough for authorised retrieval, but do not expose passwords or unnecessary security details.
What if the system changes?
Retain the old and new location, approvals, migration evidence, reconciliation and retrieval test.
Does the list replace source records?
No. It maps them; it does not substitute for their content, metadata, controls or retention.
- Singapore HSA — Clinical Trial Template Forms
- Singapore HSA — Essential Records
- ICH E6(R3) Final Guideline
- Why English? | Writing a Research Site Close-Out Visit Record
Cycle-sensitive facts were checked against current official pages on 11 October 2026. Always reopen the authority’s live page before a real decision.