A small research team does not need a hundred SOPs; it needs the right sixteen, each one page or two, each describing what you actually do. This pack gives you the standard layout, the list of SOPs to write with what each must cover, and a fully worked example to copy.
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Writing and controlling SOPs
Training and qualifications
Delegation of trial duties
Worked example below
Informed consent
Adverse event and SAE reporting
Computerised systems and data
Key points
Context
A standard operating procedure fixes a method in writing. For a research team that matters in three ways. It makes work consistent when people change, it gives new staff something to be trained on, and it gives monitors and inspectors a reference for what your team said it would do. Under E6(R2) 5.1.1 the sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs. Investigators and institutions usually work to the sponsor procedures for the trial plus their own institutional SOPs for site-level activities. E6(R3) restates quality management in a risk-proportionate way and uses different numbering, so check the current text before citing a section.
Who writes what depends on who you are. A site at a hospital often has institutional SOPs for consent, product handling and file management, and adds study-specific work instructions. A sponsor-investigator carries both roles, so the pack matters more; see how to become a sponsor-investigator. A small sponsor or academic coordinating centre needs the sponsor-side procedures too, including monitoring, safety, data management and vendor oversight. Risk-based quality management explains why proportionate is the aim.
The pack here is an outline, not a rulebook. Nothing in it replaces your institution policy or legal advice. Use it to check that you have covered the ground and to speed up drafting.
The template
Use this as the skeleton for every SOP. Aim for one to three pages. Put detail in attached forms, not in the body.
| Section | What to write | Guidance |
|---|---|---|
| Header block | SOP number, title, version, effective date, author, approver, next review date. | Same block on every page or in the footer. |
| 1. Purpose | One or two sentences: why this SOP exists. | What risk does it control? |
| 2. Scope | Who and what it applies to, and what it does not. | For example, all studies at this site, or only interventional trials. |
| 3. Definitions | Terms and abbreviations used. | Only those a new starter might not know. |
| 4. Responsibilities | Roles and what each is accountable for. | Use roles, not names. |
| 5. Procedure | Numbered steps in the order they happen, with who does each. | Write "the coordinator records", not "it is recorded". |
| 6. Records and forms | Which documents are created, where they are kept and for how long. | Link to templates such as logs and forms. |
| 7. Deviations and exceptions | What to do if the SOP cannot be followed. | Document and tell the quality owner. |
| 8. References | Regulations, guidelines and related SOPs. | Cite by name and version, and review when they change. |
| 9. Revision history | Version, date, what changed, why. | Never delete a superseded version; archive it. |
If your institution or sponsor has its own SOP template, use theirs. This layout is a reasonable default when none exists.
The pack
Order is roughly the order you need them. The final column is a pointer to a related page; it is not a promise that the page is the SOP.
| No. | SOP | Must cover | Related |
|---|---|---|---|
| 001 | Writing, approving and controlling SOPs | Layout, numbering, approval, distribution, review cycle, archiving of old versions. | This page |
| 002 | Training and qualifications | GCP and protocol training, CV and licence checks, training records, retraining. | Site initiation visit checklist |
| 003 | Delegation of trial duties | Who delegates, how tasks are listed, signature and date rules, changes. | Delegation log template |
| 004 | Informed consent | Information given, time to decide, who may consent, documentation, re-consent triggers. | Informed consent form generator |
| 005 | Screening, eligibility and enrolment | Screening log, eligibility sign-off, participant numbering, screen failures. | Screening and enrollment log |
| 006 | Source documents and CRF completion | What is source, contemporaneous entry, corrections, who may enter data. | eCRF completion guidelines |
| 007 | Adverse event and SAE reporting | Definitions, assessment, timelines, who reports to whom, follow-up. | SAE report form |
| 008 | Investigational product management | Receipt, storage, dispensing, returns, destruction, accountability. | IMP accountability log |
| 009 | Protocol deviations and serious breaches | Definition, classification, reporting, corrective and preventive action. | Deviation tracking |
| 010 | Corrections, late entries and notes to file | When each is used, wording, dating, signatures, filing. | Note to file template |
| 011 | Essential documents and file management | Site file and trial master file structure, filing timelines, completeness checks. | Site file index |
| 012 | Monitoring and audit readiness | Visit preparation, access to records, findings, follow-up, inspection handling. | Monitoring visit report |
| 013 | Computerised systems and electronic data | Selection, validation, access control, audit trail, backup, change control. | CSV for trial software |
| 014 | Data management and database lock | Data management plan, queries, coding, review, lock and unlock. | Data management plan template |
| 015 | Privacy and confidentiality | Identifiers, access, transfer, retention, breach handling. | GDPR DPIA template |
| 016 | Archiving and study close-out | Retention period, location, access, destruction, final reconciliation. | Data archiving and retention |
A sponsor-investigator will need all sixteen; a site working to institutional SOPs may only add study-specific work instructions. Confirm with your sponsor and institution.
Worked example
Here is a short SOP in the layout above, as a model of tone and length. All content is illustrative; adapt it to your own process before use.
SOP-003 v1.0. Delegation of trial duties. Effective 16 October 2026. Author: Quality lead. Approver: Head of research. Next review: October 2027.
1. Purpose. To make sure that every person who performs a trial-related task is qualified for it and has been given that task in writing by the investigator before they do it. 2. Scope. All interventional studies run by this group, at every site we manage. 3. Definitions. Delegation log: the study record of who may do which task. Delegated task: any trial-related activity that the investigator assigns, such as consent, eligibility assessment, product handling or data entry.
4. Responsibilities. The principal investigator decides who is qualified and signs each delegation. The study coordinator keeps the log current and checks it before each task type is first performed. Each staff member signs the log to confirm they accept the task. 5. Procedure. (1) Before the site starts, the coordinator drafts the log from the protocol task list. (2) The investigator reviews qualifications, training and workload and approves each task. (3) The staff member signs and dates; the investigator signs and dates, on or after the staff signature. (4) No task starts before both signatures. (5) When a task is added, removed or ended, the coordinator updates the log the same day and the investigator signs the change. (6) Before each monitoring visit the coordinator compares the log with the people who signed source and CRF entries.
6. Records. Delegation log, CVs, training certificates, filed in the investigator site file; retained per the archiving SOP. 7. Exceptions. If a task was done before delegation, tell the investigator the same day, raise a deviation under SOP-009, and explain the timeline in a note to file under SOP-010. 8. References. ICH E6(R2) 4.1.5 (the investigator keeps a list of appropriately qualified persons to whom significant duties are delegated) and 4.2.4; SOP-002, SOP-009, SOP-010; the current E6(R3) text. 9. Revision history. v1.0, new SOP.
Note what the example avoids: no names, no vague verbs, one task per step, a rule for the exception, and a link to related procedures. That is roughly one page.
| Site working to institution SOPs | Sponsor-investigator | Small sponsor | |
|---|---|---|---|
| Delegation and training (002, 003) | |||
| Consent and enrolment (004, 005) | |||
| Safety reporting (007) | |||
| Monitoring and audit (012) | |||
| Data and systems (013, 014) |
Set up your study in the free sandbox first, so the data, query and sign-off steps in your SOPs describe what the system really does.
How to use it
Your institution, sponsor or network may already have SOPs. Reuse and cite them; write only the gaps.
Consent, safety reporting, delegation, product handling and data integrity first. Leave the rest for later versions.
Interview the person who does the task, write what they do, then fix what should change. Do not copy another organisation without adapting it.
One author, one reviewer from the doing side, one approver. Use the header block and keep a master index.
Each person reads and signs for the SOPs that apply to them before they perform the task. Keep the record.
Annually or after a finding, an audit, or a regulatory change. Update the version and retrain.
In Capture
Capture is an all-in-one clinical trial platform, and several of the SOPs in this pack touch it: computerised systems, data management, and corrections. The platform keeps a field-level audit trail with timestamp, user, old value, new value and reason for change; role-based access with PII segregation; forms that move from draft to approved and are locked for live use; and edit checks that raise auto-queries. Write your SOPs about what your team decides and does; let the system enforce the rest, and reference the validation work you do under SOP-013.
Stage 1
DraftBuild and edit freely
Stage 2
ApprovedLocked for live use
Stage 3
In the casebookOnly approved forms
SDV requirement changed on Systolic BP
Data manager · Reason: critical safety value
Form approved: Vital Signs (VS) v2
Study owner · Locked for live use
Answer changed: Weight 68.0 to 68.5 kg
Site coordinator · Reason: transcription error
Before you approve an SOP
The person who does the task read it and recognises it.
So it survives staff changes.
Header block, effective date, review date.
One verb, one actor per step.
What is created, where kept and for how long.
What to do when the SOP cannot be followed.
Read and sign before first use.
No duplicated rules in two places.
Inspection readiness
Inspectors check three things: that the SOP exists and is current, that staff were trained on it, and that practice matches it. The commonest findings are an SOP that is out of date, a training record that is missing or later than the first use, and a gap between the written process and what staff describe. The third is avoided by writing for what is done. The first two are avoided by a master index with versions and a training matrix.
If a gap appears, log it, assess the impact and fix either the practice or the SOP. A note to file explains the history; it does not replace the fix. For preparation, see the FDA inspection checklist for clinical trial data, the EDC vendor audit checklist for systems, and clinical trial software for quality assurance.
The set depends on your role and institution. A common core covers training, delegation, informed consent, screening and enrolment, source and CRF completion, safety reporting, product handling, deviations, file management, monitoring readiness, computerised systems, privacy and archiving. The pack lists sixteen. Confirm with your sponsor and institution.
ICH E6(R2) 5.1.1 says the sponsor implements and maintains quality assurance and quality control systems with written SOPs. Investigators work to the protocol and sponsor procedures, and institutions often add their own. E6(R3) uses different numbering and a risk-proportionate approach, so check the current text.
One to three pages for most. Longer usually means the SOP mixes policy, procedure and forms. Move forms to attachments and keep the body to who does what, in order.
Use them as a starting point, but adapt them to your actual practice and roles, and check licence or reuse terms. An SOP that does not match what you do will create deviations the first time someone follows it.
Commonly annually, and also after an audit finding, a regulatory change or a process change. Record the review even when nothing changes, and retrain when the content does.
An SOP describes a process at the organisation level. A work instruction gives step-level detail for one task or one study, such as how to fill in a specific form. Many teams use a short SOP and attach work instructions.
Even small teams benefit from written procedures for consent, safety, delegation and data. You may be able to rely on institutional or sponsor SOPs for most. Where nothing exists, write short ones for the highest-risk activities first.
No. Capture is trial software, not an SOP library. It supports controls such as an audit trail, role-based access and form approval that your SOPs can reference, but the procedures themselves are yours to write and approve.
Keep exploring
Delegation log template
Records SOP-003 in practice.
Note to file template
The SOP-010 document.
Site initiation visit checklist
Training and readiness gate.
Data management plan template
Behind SOP-014.
Risk-based quality management guide
Proportionate quality.
21 CFR Part 11 compliance checklist
Computerised system controls.
Computer system validation for trial software
Behind SOP-013.
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