Clear Documentation in Clinical Trials

“The study was clean. But the documents didn’t show it. The result? Major finding. Weeks of damage control.”

Sound familiar?

In clinical research, it’s not what you did that matters most—it’s what you can prove through documentation.

I’ve seen brilliant teams lose credibility (and sleep) because their records were vague, inconsistent, or incomplete. That’s why in this edition, we’re focusing on what truly sets apart high-performing clinical teams:

✅ Clear, audit-ready documentation.

Why It Matters

Every clinical trial professional knows this: If it’s not documented, it didn’t happen.

But beyond that, how it's documented is what determines whether:

• a monitor trusts your data,

• a sponsor backs your site,

• a regulator issues a finding—or passes you by.

Let’s get tactical.

🔟 Core Clinical Documents — and How to Nail Them

Here’s a practical walk-through of 10 essential TMF documents—what they are, and how to write them like a pro. Each one includes ready-to-use language aligned with GCP and global expectations.

1. Study Protocol

Use: Passive voice + future tense

✔ “Subjects will be randomised in a 2:1 ratio.”

✘ “The patient gets the drug, and we see what happens.”

2. Informed Consent Form (ICF)

Use: Plain language, present tense, direct address

✔ “You are free to leave the study at any time.”

✘ “Subject agrees to participate…”

3. Monitoring Visit Report (MVR)

Use: Past tense, formal, structured with subheadings

✔ “Source data verification was performed for three subjects.”

✘ “I looked at the files. Everything seemed okay.”

4. Protocol Deviation Report

Use: Past passive, specific, factual

✔ “The subject received IMP prior to providing consent.”

✘ “The coordinator forgot again.”

5. Serious Adverse Event (SAE) Report

Use: Past simple, clinical tone, chronological

✔ “Subject 006 experienced vomiting and was hospitalised.”

✘ “Something bad happened…”

6. Delegation of Duties Log

Use: Formal roles, no nicknames

✔ “M. Chan – Study Nurse – Vital signs, ICF discussion”

✘ “Tom – helps out with patient stuff”

7. Training Attendance Records

Use: Past tense, clear topics

✔ “Training conducted on AE reporting, protocol v2.0”

✘ “They probably got trained earlier this month.”

8. Regulatory & Ethics Approvals

Use: Passive + precise version/date language

✔ “Protocol v4.0 approved by EC on 20 May 2025”

✘ “We got the approval—maybe July?”

9. Case Report Form (CRF)

Use: Short, standardised entries

✔ “Visit 2: 36.8°C – No AE – IMP taken on time”

✘ “He felt sick and took something.”

10. Final Clinical Study Report (CSR)

Use: Past tense, cautious interpretation

✔ “The primary endpoint was met. No new safety signals identified.”

✘ “The drug worked well for most people.”

---

🛑 5 Phrases to Avoid in Clinical Writing

If you hear or write these, pause and rephrase:

❌ “It seemed fine.” → ✔ “No discrepancies noted during SDV.”

❌ “Probably safe.” → ✔ “No AEs were reported.”

❌ “I think it’s version 3.” → ✔ “Protocol v3.1 dated 15 June 2025.”

❌ “Patient didn’t like it.” → ✔ “Subject withdrew due to perceived lack of benefit.”

❌ “Everyone knows that.” → ✔ “Training was documented on 8 July 2025.”

Before You Hit Save…

Ask yourself:

“Would this make sense to someone two years from now—with no further explanation?”

If yes, you’re on the right track.

🧠 Write for the future reviewer.

🛡️ Be specific. Be consistent.

📅 Use dates, not guesses.

🧾 Choose clarity over cleverness.

Because in clinical trials, clear documentation protects more than compliance—it protects patients.

---

Let’s Talk

💬 What’s one document you often write at work?

🧠 Which clinical document do you find most difficult to write clearly?

💡 Ever had to rewrite something that caused confusion?

👇 Share your experience in the comments. Your story might help someone else avoid a future audit finding.