---
title: "Research Protocol"
subtitle: "Title of study goes here"
author: "Version 1"
date: "`r format(Sys.time(), '%d %B, %Y')`"
output:
  html_document:
    toc: true
    toc_float: true
    number_sections: true
---

&nbsp;
<p style="text-align: left;"><span style="color: #808080;">This protocol contains all elements from the  <a href="http://www.spirit-statement.org/">SPIRIT</a> statement and was generated using <a href="http://www.github.com/awconway/spiritR/">spiritR</a></p>
&nbsp;


```{r include = FALSE}
#Create the lists by assigning values for each of the parameters in the code chunks below. Assigning values for these parameters will enable you to create an xml document to be uploaded to clinicaltrials.gov and also auto-populate some fields in your clinical trial protocol below.

# This will be easiest to complete by running ?create_ctxml() in the console so that you can see descriptions of the parameters to be included in this list in the viewer panel.

args_ctxml <- list(
org_name =
org_study_id =
brief_title =
study_acronym =
official_title = 
agency  = 
resp_party_type =
investigator_username = 
investigator_title =
brief_summary =
start_date =
primary_compl =  
study_compl = 
int_subtype =   
phase =
assignment =
allocation =
no_masking =  
masked_subject =
masked_caregiver = 
masked_investigator =
masked_assessor =
sample_size =
number_arms =
eligibility_criteria = "Inclusion Criteria

- [bullet point for each criteria]

Exclusion Criteria

- [bullet point for each criteria]",
healthy_volunteers =
genders_included =
gender_based =
min_age =
max_age =
    
#Central contact
contact_first_name = 
contact_last_name = 
contact_degrees = 
contact_phone =
contact_email =
    
#Overall official
official_first_name =
official_last_name =
official_degrees =
official_affiliation = 
official_role =
    
#Sharing statements
ipd_sharing =
ipd_description =
ipd_protocol =  
ipd_sap =
ipd_icf =
ipd_csr =
ipd_code =
ipd_time =
ipd_criteria =
ipd_url =
)
```


```{r include = FALSE}
# These are objects that can be assigned to auto-populate some relevant sections of the table in this protocol that are not required to be entered into the create_ctxml() function to be uploaded to clinicaltrials.gov
funding_statement <- # Sources of monetary support
inclusion_criteria <- # This is for the trial summary box in the protocol. Include a section of text (eg"1. Emergency admission. <br> 2." ) with <br> after each item not \n for new lines otherwise the markdown table will not be correct.
exclusion_criteria <- # This is for the trial summary box in the protocol. Include a section of text (eg"1. Emergency admission. <br> 2." ) with <br> after each item not \n for new lines otherwise the markdown table will not be correct.   
```


```{r include = FALSE}
pr_outcome_1 <- #limit 254 characters. Name of measure
pr_outcome_time_1 <- #limit 254 characters. Time point(s) at which the measurement is assessed. The specific duration of time over which each participant is assessed 
pr_outcome_desc_1 <- #Limit 999 characters. Description of the metric if not included in outcome measure title
    
#Add in any subsequent primary and secondary outcomes here.
#eg:  
#outcome_name <- #limit 254 characters. Name of measure
#outcome_time <- #limit 254 characters. Time point(s) at which the measurement is assessed The specific duration of time over which each participant is assessed 
#outcome_description <- #Limit 999 characters. Description of the metric if not included in outcome measure title

#When ready to upload to clinicaltrials.gov, ensure that all primary and secondary outcomes are added to the xml document using the add_pr_outcome() and add_sec_outcome() functions. Eg. add_pr_outcome(ctxml, pr_outome_1, pr_outcome_time_1, pr_outcome_desc_1)
```


```{r include = FALSE}
arm_label_1 <- #"Arm" means a pre-specified group or subgroup of participant(s) in a clinical trial assigned to receive specific intervention(s) (or no intervention) according to a protocol. Limit 62 characters
arm_type_1 <- #Experimental, Active comparator, Placebo Comparator, Sham Comparator, No Intervention, Other
arm_desc_1  <- #Description
#Assign objects for any subsequent arms here, including the label, type and description as per above (i.e. arm1).

#When ready to upload to clinicaltrials.gov, ensure that all arms are added to the xml document using the add_arm() function. Eg. add_arm(ctxml, arm_label_1, arm_type_1, arm_desc_1)
```


```{r include = FALSE}
int_name_1 <- #for a drug - generic name (same as in associated arm)
int_type_1 <- #Drug, Device, Biological/Vaccine, Procedure/Surgery, Radiation, Behavioural, Genetic, Dietary Supplement, Combination Product, Diagnostic Test, Other
int_desc_1 <-  #Do not repeat from arm description
#Assign objects for any subsequent arms here, including the name, type and description as per above.

#When ready to upload to clinicaltrials.gov, ensure that all interventions are added to the xml document using the add_intervention() function. Eg. add_intervention(ctxml, int_name_1, int_type_1, int_desc_1)
```


```{r include = FALSE}
condition_1 <-  # Enter MeSH term for condition being studied in the trial, or Focus of the Study
#Assign objects for any subsequent conditions here. eg. condition_2 <- "cardiac"

#When ready to upload to clinicaltrials.gov, ensure that all conditions are added to the xml document using the add_condition() function. eg add_condition(ctxml, condition_1), add_condition(ctxml, condition_2)
```


```{r include = FALSE}
keyword_1 <-  # Words or phrases that best describe the protocol. Keywords help users find studies in the database. 
#Assign objects for any subsequent keywords here. eg. keyword_2 <- "sedation"

#When ready to upload to clinicaltrials.gov, ensure that all keywords are added to the xml document using the add_keyword() function. eg. add_keyword(ctxml, keyword_1), add_keyword(ctxml, keyword_2)
```


|                               	|                       	|
|-------------------------------	|-----------------------	|
| Study Principal Investigator: 	| [enter details]       	|
| Sponsors:                     	| `r args_ctxml$resp_party_type`|
| Protocol contributors:        	| [Names and affiliations]|
| Trial identifiers:              | [enter details]    	|


<br><br>
**ABBREVIATIONS**

| Abbreviation 	| Explanation                              	|
|--------------	|------------------------------------------	|
| PHI          	| Personal Health Information              	|
| PI           	| Principal Investigator                   	|
| PICF         	| Participant Information and Consent Form 	|
| RA           	| Research Assistant                       	|
| REB          	| Research Ethics Board                    	|



<br><br>

**REVISION HISTORY** <font size="3">^[🔗](http://www.spirit-statement.org/protocol-version/)^ </font>


| Version  	| Date       	| Amendment Text 	| Description 	|
|----------	|------------	|----------------	|-------------	|
|         	|           	|                	|             	|


<br><br>

# TRIAL SUMMARY <font size="3">^[🔗](http://www.spirit-statement.org/data-set/)^ </font>

|                              | World Health Organization Registration Data Set         |
| -----------------------------| ------------------------------------------------------- |                  
| Title                        | `r args_ctxml$official_title`                                       |
| Registry identifying number  | clinicaltrials.gov|
| Secondary identifying numbers| [enter details if any]                                    |
| Sources of support        	 | `r funding_statement`                                    |
| Primary sponsor            	 | `r args_ctxml$agency`                                              |
| Secondary sponsors (if any)  | [enter details]                                         |
| Central contact   	         | `r args_ctxml$contact_first_name, args_ctxml$contact_last_name, sep=" ")`|
| Study official               | `r paste(args_ctxml$official_first_name, args_ctxml$official_last_name,sep=" ")`|
| Brief title                  | `r args_ctxml$brief_title`                                          |
| Acronym                      | `r args_ctxml$study_acronym`                                        |
| Countries of recruitment     | [enter details]   	                                     |
| Condition(s) or study focus  | `r condition_1`; `r keyword_1`            |
| **Interventions**            |                                                         |
| `r int_name_1`               | Type: `r int_type_1`<br><br> Description: `r int_desc_1`|
| **Key eligibility criteria **|                                                         |
| Age eligibility:             | `r paste(args_ctxml$min_age, args_ctxml$max_age, sep = " - ")`                  |
| Accepts healthy volunteers   | `r args_ctxml$healthy_volunteers`                                   |
| Inclusion criteria           | `r inclusion_criteria`                                   |
| Exclusion criteria           | `r exclusion_criteria`                                   |
| **Study design**             |                                                         |
| Study type                   | Interventional trial                                    | 
| Allocation                   | `r args_ctxml$allocation`                                    |
| Intervention model           | `r args_ctxml$assignment`                                    |
| Primary purpose              | `r args_ctxml$int_subtype`                               |
| Phase                        | `r args_ctxml$phase`                                               | 
| **Masking**   	             |                                                         |
| Participant                  | `r args_ctxml$masked_subject`                                       |
| Care Provider                | `r args_ctxml$masked_caregiver`                                     |
| Investigator                 | `r args_ctxml$masked_investigator`                                  |      
| Outcomes Assessor            | `r args_ctxml$masked_assessor`	                                     |
| **Date of enrollment**       | `r paste("Anticipated", args_ctxml$start_date, sep = ": ")`  	                                       |
| **Target sample size**       | `r args_ctxml$sample_size`  	                                       |
| **Recruitment status**       | Not yet recruiting 	                                   |
| **Primary outcomes**         |                                                         |
| **Primary outcomes**         |                                               |
| `r pr_outcome_1`          | Timeframe: `r pr_outcome_time_1`<br><br>Description: `r pr_outcome_desc_1`|
| **Secondary outcomes **  	   |                            |
| [enter inline rcode for secondary outome name] | Timeframe: [enter inline rcode]<br><br>Description:[enter inline rcode]|

<br>
<br>

# INTRODUCTION

## Background and rationale <font size="3">^[🔗](http://www.spirit-statement.org/background-and-rationale/)^ </font>



## Objectives <font size="3">^[🔗](http://www.spirit-statement.org/objectives/)^ </font>



## Trial design <font size="3">^[🔗](http://www.spirit-statement.org/trial-design/)^ </font>





# METHODS

## Study setting <font size="3">^[🔗](http://www.spirit-statement.org/study-setting/)^ </font>



## Eligibility criteria <font size="3">^[🔗](http://www.spirit-statement.org/eligibility-criteria/)^ </font>

### Inclusion criteria 

`r inclusion_criteria`

### Exclusion criteria

`r exclusion_criteria`

## Interventions <font size="3">^[🔗](http://www.spirit-statement.org/interventions/)^ </font>

### Intervention description



>Intervention

`r int_name_1`

*Type*: `r int_type_1`

*Description*: `r int_desc_1`

>Comparison




### Modifications <font size="3">^[🔗](http://www.spirit-statement.org/modifications/)^ </font>





### Adherence <font size="3">^[🔗](http://www.spirit-statement.org/adherence/)^ </font>




### Concomitant care <font size="3">^[🔗](http://www.spirit-statement.org/concomitant-care/)^ </font>



## Outcomes <font size="3">^[🔗](http://www.spirit-statement.org/outcomes-2/)^ </font>



>Primary outcome: `r pr_outcome_1`

*Timeframe*: `r pr_outcome_time_1`

*Description*: `r pr_outcome_desc_1`


>Secondary outcomes




## Participant timeline <font size="3">^[🔗](http://www.spirit-statement.org/participant-timeline/)^ </font>





| STUDY PERIOD                	|           	|            	|                 	|    	|    	|    	|      	|           	|
|-----------------------------	|:---------:	|:----------:	|:---------------:	|:--:	|:--:	|:--:	|:----:	|:---------:	|
|                             	| Enrolment 	| Allocation 	| Post-allocation 	|    	|    	|    	|      	| Close-out 	|
| TIMEPOINT**                 	|     0     	|      0     	|        t1       	| t2 	| t3 	| t4 	| etc. 	|     tx    	|
| ENROLMENT:                  	|           	|            	|                 	|    	|    	|    	|      	|           	|
| Eligibility screen          	|     X     	|            	|                 	|    	|    	|    	|      	|           	|
| Informed consent            	|     X     	|            	|                 	|    	|    	|    	|      	|           	|
| [List other procedures]     	|     X     	|            	|                 	|    	|    	|    	|      	|           	|
| Allocation                  	|           	|      X     	|                 	|    	|    	|    	|      	|           	|
| INTERVENTIONS:              	|           	|            	|                 	|    	|    	|    	|      	|           	|
| [Intervention A]            	|           	|            	|                 	|    	|    	|    	|      	|           	|
| [Intervention B]            	|           	|            	|        X        	|    	|  X 	|    	|      	|           	|
| [List other study groups]   	|           	|            	|                 	|    	|    	|    	|      	|           	|
| ASSESSMENTS:                	|           	|            	|                 	|    	|    	|    	|      	|           	|
| [List baseline variables]   	|     X     	|      X     	|                 	|    	|    	|    	|      	|           	|
| [List outcome variables]    	|           	|            	|                 	|  X 	|    	|  X 	| etc. 	|     X     	|
| [List other data variables] 	|           	|            	|        X        	|  X 	|  X 	|  X 	| etc. 	|     X     	|



## Sample size <font size="3">^[🔗](http://www.spirit-statement.org/sample-size/)^ </font>

The sample size for this study is `r args_ctxml$sample_size`.

## Recruitment <font size="3">^[🔗](http://www.spirit-statement.org/recruitment/)^ </font>



## Allocation

### Sequence generation <font size="3">^[🔗](http://www.spirit-statement.org/sequence-generation/)^ </font>


### Concealment mechanism <font size="3">^[🔗](http://www.spirit-statement.org/concealment-mechaninism/)^ </font>


### Implementation <font size="3">^[🔗](http://www.spirit-statement.org/implementation/)^ </font>

## Blinding (masking)

### Blinding mechanism <font size="3">^[🔗](http://www.spirit-statement.org/blinding-masking/)^ </font>



### Emergency unblinding <font size="3">^[🔗](http://www.spirit-statement.org/emergency-unblinding/)^ </font>


## Data collection <font size="3">^[🔗](http://www.spirit-statement.org/data-collection-methods/)^ </font>

### Trial procedures and evaluations



### Retention <font size="3">^[🔗](http://www.spirit-statement.org/retention/)^ </font>


## Data management <font size="3">^[🔗](http://www.spirit-statement.org/data-management/)^ </font>

**Data Forms and Data Entry**




**Data Transmission and Editing**




**Security and Back-Up of Data**




**Study status reports**



## Statistical methods

### Outcomes <font size="3">^[🔗](http://www.spirit-statement.org/outcomes/)^ </font>


### Additional analyses <font size="3">^[🔗](http://www.spirit-statement.org/additional-analyses/)^ </font>



### Analysis population and missing data <font size="3">^[🔗](http://www.spirit-statement.org/objectives/)^ </font>


## Data monitoring

### Formal committee <font size="3">^[🔗](http://www.spirit-statement.org/formal-committee/)^ </font>


### Interim analysis <font size="3">^[🔗](http://www.spirit-statement.org/interim-analysis/)^ </font>


## Safety/harms <font size="3">^[🔗](http://www.spirit-statement.org/harms/)^ </font>



## Auditing <font size="3">^[🔗](http://www.spirit-statement.org/auditing/)^ </font>






# ETHICS AND DISSEMINATION

## Research ethics approval <font size="3">^[🔗](http://www.spirit-statement.org/research-ethics-approval/)^ </font>




## Protocol amendments <font size="3">^[🔗](http://www.spirit-statement.org/protocol-amendments/)^ </font>




## Informed consent process <font size="3">^[🔗](http://www.spirit-statement.org/consent-or-assent/)^ </font>



### Ancillary studies <font size="3">^[🔗](http://www.spirit-statement.org/ancillary-studies/)^ </font>



## Confidentiality <font size="3">^[🔗](http://www.spirit-statement.org/confidentiality/)^ </font>





## Declaration of interests <font size="3">^[🔗](http://www.spirit-statement.org/declaration-of-interests/)^ </font>



## Access to data <font size="3">^[🔗](http://www.spirit-statement.org/access-to-data/)^ </font>


## Ancillary and post-trial care <font size="3">^[🔗](http://www.spirit-statement.org/ancillary-and-post-trial-care/)^ </font>





## Dissemination policy 

### Trial results <font size="3">^[🔗](http://www.spirit-statement.org/31a-trial-results/)^ </font>


### Authorship <font size="3">^[🔗](http://www.spirit-statement.org/31b-authorship/)^ </font>



### Reproducible research <font size="3">^[🔗](http://www.spirit-statement.org/31c-reproducible-research/)^ </font>

*Inidividual participant data sharing statement*

`r args_ctxml$ipd_description`

*Individual participant data sharing time-frame statement*

`r args_ctxml$ipd_time`



# STUDY ADMINISTRATION

## Key contacts

**Study Principal Investigator**



**Central contact**

`r paste(args_ctxml$contact_first_name, args_ctxml$contact_last_name, sep = " ")`

Phone: `r args_ctxml$contact_phone`

Email:`r args_ctxml$contact_email`


**Sponsor**

`r args_ctxml$agency`



## Funders <font size="3">^[🔗](http://www.spirit-statement.org/funding/)^ </font>

`r funding_statement`



## Roles and responsibilities

### Protocol contributors <font size="3">^[🔗](http://www.spirit-statement.org/contributorship/)^ </font>



### Sponsor and funder <font size="3">^[🔗](http://www.spirit-statement.org/sponsor-and-funder/)^ </font>


### Trial committees <font size="3">^[🔗](http://www.spirit-statement.org/committees/)^ </font>

N/A



# REFERENCES

# Appendix

## Informed consent materials <font size="3">^[🔗](http://www.spirit-statement.org/informed-consent-materials/)^ </font>


## Biological specimens <font size="3">^[🔗](http://www.spirit-statement.org/biological-specimens/)^ </font>