EditverseEthics, consent and trial registration pack
from $450See levels and order
Before a study can enrol, the ethics committee must approve it and, for clinical trials, a registry record must be public. This pack prepares those documents from your protocol. It is for investigators, thesis candidates running clinical studies, and sponsors of single-site studies who want the application right the first time.
Specification
- You provide
- The protocol or approved synopsis, the committee's current application forms, site and investigator details, and the registry you will use (ClinicalTrials.gov, CTRI or equivalent).
- We do
- Complete the application form from the protocol, write the participant summary in plain language, prepare the text for each registry field, and draft replies to the committee's queries.
- You receive
- Completed application draft on the committee's form, registry record text ready to paste field by field, and at Advanced a plain-language participant summary.
- Standard applied
- ICH E6(R3) Good Clinical Practice, Principles and Annex 1; WHO Trial Registration Data Set, version 1.3.1 (24 items); ICMJE Recommendations, January 2026, on registration before first enrolment; 42 CFR Part 11 for applicable US trials; your committee's own rules.
- Turnaround
- 5 to 7 business days.
- Revision rounds
- 1 round, plus drafted replies to committee queries on the documents we prepared.
- Team
- A medical writer experienced in clinical documents and a subject-matter expert (MD or PhD in the study's field).
Levels
The two priced levels differ by one document. Multi-site consent sets are by quote.
| What is included | Basic $450 | Advanced $575 | Multi-site consent set, by quote |
|---|---|---|---|
| Ethics committee or IRB application draft | |||
| Trial registry record text | |||
| Plain-language participant summary | |||
| Full informed consent form set with site-specific versions | |||
| Replies to committee queries | |||
| Revision rounds | 1 | 1 | Agreed in the quote |
The quote for a multi-site or sponsored-trial consent set depends on the number of sites and countries, the number of consent documents (main, assent, optional sub-studies) and whether translations are needed.
How the work is checked
- Every answer on the form is traced to a section of the protocol, so the application and the protocol cannot disagree.
- Registry text is checked against the 24 items of the WHO Trial Registration Data Set, version 1.3.1, including primary outcome, key secondary outcomes and sample size.
- The participant summary is read for plain language by a reviewer outside the study's specialty.
- Risks, procedures and visit burden in the participant summary are reconciled with the protocol's schedule.
- Dates, version numbers and investigator details are consistent across all documents.
Editverse Medical work is aligned with COPE, ICMJE and GPP 2022; institutional and country-specific ethics requirements are followed. Authors keep authorship and accountability.
Not included
Submission to the committee or registry, signatures, committee fees and translation into local languages are handled by the study team.
Ordering and payment
Order and pay now by invoice if your protocol is final. If you would rather see the work first, press Request this service, send the protocol and forms, and pay after the first draft is delivered, only if it meets your expectations. Documents may be submitted once payment is made. An official invoice and receipt are available, and multi-site scopes are quoted.
Questions about this service
When does a trial have to be registered?
ICMJE member journals require registration in a public registry before the first participant is enrolled (ICMJE Recommendations, January 2026). For applicable clinical trials in the US, 42 CFR Part 11 sets a legal limit of 21 calendar days after first enrolment. Register before enrolment and both are met.
My protocol is still a synopsis. Is that enough?
For many committees and thesis studies, yes. The form is completed from the approved synopsis and any missing items are listed for you to decide.
Do you create the registry account and submit?
No. The record must be owned by the investigator or sponsor. You receive text for each field and paste it into your own account.
What happens if the committee asks questions?
Send the query letter. Replies are drafted for the points that concern the documents prepared here, and the documents are amended to match.
Part of Clinical study reports. Related: Clinical Study Protocol and Thesis Synopsis, Literature Review and Ethics Submission.
Order this service
from $450