Protocol project template

This page is for

Organizational Administrators | Unit Leads | Individual subscribers | Cochrane users

Cochrane Support open all RevMan projects other than 'Evidence surveillance'. See Cochrane project management.

Step-by-step guidance for protocol authors

This page was developed by Cochrane methods experts and takes you through the process of drafting your protocol for submission. Linked guidance and training is shown for each step.

Protocol milestones:

1. Define question(s)

Start by defining the scope of your review and the questions you want to answer. The suggested timeframe for completing this milestone is 1 week.

1. Formulate review question(s)

Resource	Link
Cochrane Handbook	Determining the scope of the review and the questions it will address
Methodological Expectations of Cochrane Intervention Reviews (MECIR) - mandatory conduct standards	Setting the research question to inform the scope of the review (C1-C4)
Cochrane Interactive Learning	Module 1: Introduction to conducting systematic reviews
Learning resource	How to involve patients and the public in your review
Webinar	How to overcome the challenges of reviewing adverse effects (Part 1: Adverse effects vs intended outcomes and Part 2: Formulating review question for adverse effects)
Micro-module (5 mins)	What makes a good review question?
Methods Support Unit web clinic	Considering scope at the review planning stage
	How to approach writing a Background section
	A checklist and guide for defining the questions to be addressed in the synthesis of public health intervention reviews

2. Define objective(s)

Resource	Link
Cochrane Handbook	Determining the scope of the review and the questions it will address
Methodological Expectations of Cochrane Intervention Reviews (MECIR) - mandatory conduct standards	Setting the research question to inform the scope of the review (C1-C4)
Cochrane Interactive Learning	Module 2: Writing the review protocol
Methods Support Unit web clinic	Considering scope at the review planning stage
Methods Support Unit web clinic	How to approach writing a Background section

2. Define eligibility criteria

What types of studies will you include in your review? The suggested timeframe for completing this milestone is 1 week.

1. Define eligibility criteria

Resource	Link
Cochrane Handbook	Defining the criteria for including studies and how they will be grouped for the synthesis
Methodological Expectations of Cochrane Intervention Reviews (MECIR) - mandatory conduct standards	Setting eligibility criteria for including studies in the review (C5-C13)
	Selecting outcomes to be addressed for studies included in the review (C14-C18)
Core Outcome Measures in Effectiveness Trials	Standard outcome sets defined by COMET
Cochrane Interactive Learning	Module 2: Writing the review protocol
Webinar	How to overcome the challenges of reviewing adverse effects (part 3: Constructing a PICO and deciding on eligible study designs)
Methods Support Unit web clinic	Considering scope at the review planning stage

3. Plan methods

How do you plan to conduct your review? Your methods are the most important part of your protocol. Take your time and contact our Methods Support unit if you have questions. The suggested timeframe for completing this milestone is 4 weeks.

1. Plan search and develop search strategies

Resource	Link
Cochrane Handbook	Designing search strategies
Cochrane Interactive Learning	Module 3: Searching for studies
Webinar	Searching for adverse effects

2. Plan study selection

Resource	Link
Cochrane Handbook	Determining which study designs to include
	Identifying multiple reports from the same study
	Eligibility based on publication status and language
Cochrane Interactive Learning	Module 4: Selecting studies and collecting data

3. Plan synthesis of results

Resource	Link
Cochrane Handbook	Choosing effect measures and computing estimates of effect
	Summarizing study characteristics and preparing for synthesis
	Analysing data and undertaking meta-analyses
	Undertaking network meta-analyses
	Synthesizing and presenting findings using other methods
Methodological Expectations of Cochrane Intervention Reviews (MECIR) - mandatory conduct standards	Planning the review methods at protocol stage (C19-C23)C
RevMan Knowledge Base	Plan: define analyses and risk of bias
Cochrane Methodology	Network meta-analysis (NMA)
Cochrane Interactive Learning	Module 6: Analysing the data
Cochrane Interactive Learning	Module 10: Network meta-analysis

4. Plan data extraction

Resource	Link
Cochrane Handbook	Collecting data
Methodological Expectations of Cochrane Intervention Reviews (MECIR) - mandatory conduct standards	Collecting data from included studies (C43-C51)
RevMan Knowledge Base	Prepare: extract study data
Cochrane Interactive Learning	Module 4: Selecting studies and collecting data

5. Plan assessment of methodological limitations

Resource	Link
Cochrane Handbook	Considering bias and conflicts of interest among the included studies
	Assessing risk of bias in a randomized trial
	Assessing risk of bias due to missing results in a synthesis
	Assessing risk of bias in a non-randomized study
Methodological Expectations of Cochrane Intervention Reviews (MECIR) - mandatory conduct standards	Assessing risk of bias in included studies (C52-C60)
RevMan Knowledge Base	Plan: define analyses and risk of bias
Cochrane Methods	Risk of Bias 2 (RoB 2) tool
Risk of bias group	Risk of Bias tools
Cochrane Interactive Learning	Module 5: Introduction to risk of bias
Methods Support Unit web clinic	Risk of Bias 2: Good practice and common errors
Webinar	How to overcome the challenges of reviewing adverse effects (Part 5: Risk of bias assessment, selective non-reporting and bias in the review process)

6. Plan presentation of summary of findings

Resource	Link
Cochrane Handbook	Completing ‘Summary of findings’ tables and grading the certainty of the evidence
GRADE Handbook	Summary of Findings table
Cochrane Interactive Learning	Module 8: Reporting the review

7. Plan certainty/strength assessment

Resource	Link
Cochrane Handbook	Interpreting results and drawing conclusions
GRADE Handbook	Quality of evidence
Cochrane Interactive Learning	Module 7: Interpreting the findings

4. Prepare manuscript for submission

Protocols should be concise and follow the Cochrane review template, available as a practice review in RevMan. The suggested timeframe for completing this milestone is 7 weeks.

1. Write background

Resource	Link
Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)	PRISMA Checklist
Cochrane author guidelines	Pre-submission checklist
Methods Support Unit web clinic	How to approach writing a Background section
Webinar	Writing a review protocol – good practice and common errors (Part 1, 2:47-7:34)

2. Formulate the objective

Resource	Link
Methodological Expectations of Cochrane Intervention Reviews (MECIR) - mandatory conduct standards	Setting the research question to inform the scope of the review (C1-C4)
Methods Support Unit web clinic	A checklist and guide for defining the questions to be addressed in the synthesis of public health intervention reviews
Webinar	Writing a review protocol – good practice and common errors (Part 1, 7:35-25:30)

3. Write the methods

Resource	Link
Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)	PRISMA Checklist
Cochrane Interactive Learning	Module 2: Writing the review protocol
Webinar	Writing a review protocol – good practice and common errors (Part 2)

4. Complete additional information

Resource	Link
Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)	PRISMA for systematic review protocols (PRISMA-P)
Cochrane author guidelines	Pre-submission checklist
RevMan Knowledge Base	Validation report

5. Internal feedback

Resource	Link
RevMan Knowledge Base	Compare versions

6. Complete pre-submission checks

Resource	Link
Cochrane author guidelines	Pre-submission checklist
RevMan Knowledge Base	How to use the Cochrane review template

7. Submit first draft

Resource	Link
Editorial Manager instructions	Submit the first draft of your protocol

5. Editorial process

1. Address editorial and peer reviewer comments

Resource	Link
Cochrane author guidelines	Peer review

2. Internal feedback: revision 1

Resource	Link
RevMan Knowledge Base	Compare versions

3. Submit revision 1

Resource	Link
Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)	PRISMA for systematic review protocols (PRISMA-P)
Cochrane author guidelines	Pre-submission checklist
Cochrane author guidelines	Submission deadlines
Editorial Manager instructions	Resubmit following revisions
RevMan Knowledge Base	Compare versions
RevMan Knowledge Base	Validation report

4. Address editorial and peer reviewer comments (2)

Resource	Link
Cochrane author guidelines	Peer review

5. Internal feedback: revision 2

Resource	Link
RevMan Knowledge Base	Compare versions

6. Submit revision 2

Resource	Link
Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)	PRISMA for systematic review protocols (PRISMA-P)
Cochrane author guidelines	Pre-submission checklist
Cochrane author guidelines	Submission deadlines
Editorial Manager instructions	Resubmit following revisions
RevMan Knowledge Base	Compare versions
RevMan Knowledge Base	Validation report

6. Prepare manuscript for publication

1. Complete licence for publication

Resource	Link
Cochrane author guidelines	Copyright and licensing
Editorial Manager instructions	Complete your Licence for Publication Form

2. Address copy edit comments

Resource	Link
Cochrane author guidelines	Proofs
Editorial Manager instructions	Review final proofs after copy-editing