Quality Solutions · Template Portal

Controlled templates for trials built to be audited.

Start with free checklists and guides for study managers, CRAs and CRCs. Subscribe for the full library of sponsor templates, mapped to ICH E6(R3) and ready to enter your quality system.

What's inside
Free
Checklists, guides and worksheets by role
Library
Sponsor plans, SOPs, logs and registers in Word and Excel
Updates
New versions with a summary of changes while you subscribe
Free · work email required

Free tools for the study team.

Each tool cites the requirement it supports. Sign up with your work email and we'll send the download link.

F-01
ICH E6(R3): What Changed
Guide · ICH E6(R3) · Study managers
Free
F-02
Vendor Oversight Checklist
Checklist · ICH E6(R3) Annex 1 Section 3.6 · Study managers
Free
F-03
TMF Health Check
Checklist · ICH E6(R3) Annex 1 Section 3.16; Appendix C · Study managers
Free
F-04
Inspection Readiness Checklist
Checklist · FDA Compliance Program 7348.810 · Study managers
Free
F-05
Critical-to-Quality Risk Worksheet
Worksheet · ICH E8(R1) Section 3; ICH E6(R3) Section 3.10 · Study managers
Free
F-06
Site Qualification Visit Checklist
Checklist · ICH E6(R3) · CRAs
Free
F-07
Site Initiation Visit Checklist
Checklist · ICH E6(R3) Annex 1 Sections 3.11.4, 2.1, 2.3 · CRAs
Free
F-08
Risk-Based Monitoring Visit Guide
Guide · ICH E6(R3) Annex 1 Section 3.11.4 · CRAs
Free
F-09
SDV and SDR Quick Guide
Quick guide · ICH E6(R3) · CRAs
Free
F-10
Close-out Visit Checklist
Checklist · ICH E6(R3) Annex 1 Sections 2.13, 3.16, 3.17 · CRAs
Free
F-11
Informed Consent Process Checklist
Checklist · 21 CFR 50.20, 50.25, 50.27; ICH E6(R3) Annex 1 Section 2.8 · CRCs
Free
F-12
Investigator Site File Checklist
Checklist · ICH E6(R3) Annex 1 Section 2.12; Appendix C · CRCs
Free
F-13
AE and SAE Reporting Timelines
Quick guide · 21 CFR 312.32, 312.64; 21 CFR 812.150 · CRCs
Free
F-14
Delegation Log and Training Checklist
Checklist · ICH E6(R3) Annex 1 Sections 2.1, 2.3; 21 CFR 312.53(c) · CRCs
Free
F-15
Protocol Deviation Records Guide
Guide · ICH E6(R3) · CRCs
Free
Subscription · Template Portal

The full sponsor library.

Every template has document control, a requirement map, instructions and an approval history. Files are unbranded, so they enter your QMS under your own document control.

ICH E6(R3)
TMF plan and index
ER-02
ICH E6(R3)
Vendor oversight plan
SP-02
21 CFR 312.32; 21 CFR 812.150
Trial safety reporting plan
SP-08
ICH E6(R3)
Data management plan
DG-01
ISO 14155:2020
Clinical investigation plan
PR-07
ICH E6(R3)
Risk-based monitoring plan
SP-05
ICH E6(R3)
Protocol deviation SOP and log
PR-06 · PR-03 · QM-05
21 CFR Part 50
Informed consent template
IC-01
21 CFR Part 11
Computerized system assessment
DG-09
FDA Compliance Program 7348.810
Inspection readiness plan
QA-05 · QA-03
ICH E6(R3)
Quality risk management plan
QM-02 · QM-01 · QM-03
ICH E6(R3); ISO 13485:2016
CAPA SOP
QM-07 · QM-06
ICH E6(R3)
Site selection and qualification
SP-04
ICH E6(R3)
Delegation and training logs
IN-02 · IN-04
ICH E3
Clinical study report outline
RP-01
Pricing

One subscription per organization.

Prices in US dollars. Annual plans can be paid by card or bank transfer (ACH).

Annual
$2,400 a year
  • The full library, Word and Excel
  • Every new version while you subscribe
  • The Gray Letter for your team, included
  • Up to 5 named users
Subscribe for $2,400 a year
Monthly
$299 a month
  • Everything in Annual
  • 3-month minimum: $897 for the first 3 months
  • Then $299 a month until you cancel
Start for $897
Questions

Before you subscribe

How do I get access after I pay?

Access is set up automatically as soon as payment goes through, for your email and up to 4 team emails you enter at checkout (5 in total). Each person signs in at the library with their work email and a one-time code sent by email.

Can I use the templates after I cancel?

Yes. Versions you downloaded while subscribed stay licensed for the trials you used them on. New downloads and updates stop when the subscription ends.

Are the templates branded?

No. They are unbranded so they enter your quality system under your own document control.

How do I change payment details or cancel?

Use the billing link in the library, or email [EMAIL].