User Guide

User Guide

User guide for trial register

Part 1

*Public title

Title intended for the lay public in easily understood language.

*Scientific title

Scientific title of the study as it appears in the protocol submitted for funding and ethical review. Include trial acronym if available.

Trial Acronyms

Type none if no data available

*Type of registration

Retrospective

Prospective

*Brief summary

Prove a short description of the primary purpose of the protocol including a brief statement of the study hypothesis

Secondary ID

Secondary identifiers include those issued by other Primary Registries, but may also include numbers issued by agencies such as funding bodies or collaborative research groups.

*Principal Investigator (Trail coordinator for multicentric study add new)

Name

Email

Contact no.

Designation

Organizational affiliation

Address

Country (Press & Hold Ctrl Key to Select Multiple Countries)

Add another principal investigator button (About 5 button more)

*Principal Investigator (Trail coordinator for multicentric study add new)

Name

Email

Contact no.

Designation

Organizational affiliation

Address

Country (Press & Hold Ctrl Key to Select Multiple Countries)

*Principal Investigator (Trail coordinator for multicentric study add new)

Name

Email

Contact no.

Designation

Organizational affiliation

Address

Country (Press & Hold Ctrl Key to Select Multiple Countries)

*Principal Investigator (Trail coordinator for multi centric study add new)

Name

Email

Contact no.

Designation

Organizational affiliation

Address

Country (Press & Hold Ctrl Key to Select Multiple Countries)

No. of Selected Countries:

Afghanistan

Albania

Algeria

Andorra

Angola

Anguilla

Antigua and Barbuda

Argentina

Armenia

Aruba

Australia

Austria

Azerbaijan

Bahamas

Bahrain

Bangladesh

Barbados

Belarus

Belgium

Belize

Benin

Bermuda

Bhutan

Bolivia

Bosnia and Herzegovina

Botswana

Brazil

British Virgin Islands

Brunei

Bulgaria

Burkina Faso

Burundi

Cabo Verde

Cambodia

Cameroon

Canada

CAR

Caribbean Netherlands

Cayman Islands

Chad

Channel Islands

Chile

China

Colombia

Comoros

Congo

Costa Rica

Croatia

Cuba

Curaçao

Cyprus

Czechia

Denmark

Diamond Princess

Djibouti

Dominica

Dominican Republic

DRC

Ecuador

Egypt

El Salvador

Equatorial Guinea

Eritrea

Estonia

Eswatini

Ethiopia

Faeroe Islands

Falkland Islands

Fiji

Finland

France

French Guiana

French Polynesia

Gabon

Gambia

Georgia

Germany

Ghana

Gibraltar

Greece

Greenland

Grenada

Guadeloupe

Guatemala

Guinea

Guinea-Bissau

Guyana

Haiti

Honduras

Hong Kong

Hungary

Iceland

India

Indonesia

Iran

Iraq

Ireland

Isle of Man

Israel

Italy

Ivory Coast

Jamaica

Japan

Jordan

Kazakhstan

Kenya

Kuwait

Kyrgyzstan

Laos

Latvia

Lebanon

Lesotho

Liberia

Libya

Liechtenstein

Lithuania

Luxembourg

Macao

Madagascar

Malawi

Malaysia

Maldives

Mali

Malta

Martinique

Mauritania

Mauritius

Mayotte

Mexico

Moldova

Monaco

Mongolia

Montenegro

Montserrat

Morocco

Mozambique

MS Zaandam

Myanmar

Namibia

Nepal

Netherlands

New Caledonia

New Zealand

Nicaragua

Niger

Nigeria

North Macedonia

Norway

Oman

Pakistan

Palestine

Panama

Papua New Guinea

Paraguay

Peru

Philippines

Poland

Portugal

Qatar

Romania

Russia

Rwanda

Réunion

S. Korea

Saint Kitts and Nevis

Saint Lucia

Saint Martin

Saint Pierre Miquelon

San Marino

Sao Tome and Principe

Saudi Arabia

Senegal

Serbia

Seychelles

Sierra Leone

Singapore

Sint Maarten

Slovakia

Slovenia

Somalia

South Africa

South Sudan

Spain

Sri Lanka

St. Barth

St. Vincent Grenadines

Sudan

Suriname

Sweden

Switzerland

Syria

Taiwan

Tajikistan

Tanzania

Thailand

Timor-Leste

Togo

Trinidad and Tobago

Tunisia

Turkey

Turks and Caicos

UAE

Uganda

UK

Ukraine

Uruguay

USA

Uzbekistan

Vatican City

Venezuela

Vietnam

Western Sahara

Yemen

Zambia

Zimbabwe

Name, designation and address of Principal Investigator should be mentioned. For a multi-center study, enter the contact information for the lead Principal Investigator or overall Trial Coordinator. Address should include contact numbers and email ID. Email ID should be personal and not a general ID (e.g. info@gmail.com), which may not be accessed regularly by the designated person. The designated person should be from Nepal.

*Contact person (scientific query) (Same as above)

Yes

No

If no,

Name

Email

Contact no.

Designation

Organizational affiliation

Address

Country

Name, designation and address of contact person for scientific queries about the trial should be mentioned. The address should include contact numbers and email ID, along with affiliation of the local person (in case of multi-country trial) who will respond to general queries, including information about current recruitment status. This may or may not be the same as the contact person for public queries. The email ID should be personal and not a general ID (e.g. info@gmail.com), which may not be accessed regularly by the designated person.

*Contact person (Public Query) (Same as above)

Yes

No

If no,

Name

Email

Contact no.

Designation

Organizational affiliation

Address

Country (Press & Hold Ctrl Key to Select Multiple Countries)

No. of Selected Countries: [Automatic generated]

Afghanistan

Albania

Algeria

Andorra

Angola

Anguilla

Antigua and Barbuda

Argentina

Armenia

Aruba

Australia

Austria

Azerbaijan

Bahamas

Bahrain

Bangladesh

Barbados

Belarus

Belgium

Belize

Benin

Bermuda

Bhutan

Bolivia

Bosnia and Herzegovina

Botswana

Brazil

British Virgin Islands

Brunei

Bulgaria

Burkina Faso

Burundi

Cabo Verde

Cambodia

Cameroon

Canada

CAR

Caribbean Netherlands

Cayman Islands

Chad

Channel Islands

Chile

China

Colombia

Comoros

Congo

Costa Rica

Croatia

Cuba

Curaçao

Cyprus

Czechia

Denmark

Diamond Princess

Djibouti

Dominica

Dominican Republic

DRC

Ecuador

Egypt

El Salvador

Equatorial Guinea

Eritrea

Estonia

Eswatini

Ethiopia

Faeroe Islands

Falkland Islands

Fiji

Finland

France

French Guiana

French Polynesia

Gabon

Gambia

Georgia

Germany

Ghana

Gibraltar

Greece

Greenland

Grenada

Guadeloupe

Guatemala

Guinea

Guinea-Bissau

Guyana

Haiti

Honduras

Hong Kong

Hungary

Iceland

India

Indonesia

Iran

Iraq

Ireland

Isle of Man

Israel

Italy

Ivory Coast

Jamaica

Japan

Jordan

Kazakhstan

Kenya

Kuwait

Kyrgyzstan

Laos

Latvia

Lebanon

Lesotho

Liberia

Libya

Liechtenstein

Lithuania

Luxembourg

Macao

Madagascar

Malawi

Malaysia

Maldives

Mali

Malta

Martinique

Mauritania

Mauritius

Mayotte

Mexico

Moldova

Monaco

Mongolia

Montenegro

Montserrat

Morocco

Mozambique

MS Zaandam

Myanmar

Namibia

Nepal

Netherlands

New Caledonia

New Zealand

Nicaragua

Niger

Nigeria

North Macedonia

Norway

Oman

Pakistan

Palestine

Panama

Papua New Guinea

Paraguay

Peru

Philippines

Poland

Portugal

Qatar

Romania

Russia

Rwanda

Réunion

S. Korea

Saint Kitts and Nevis

Saint Lucia

Saint Martin

Saint Pierre Miquelon

San Marino

Sao Tome and Principe

Saudi Arabia

Senegal

Serbia

Seychelles

Sierra Leone

Singapore

Sint Maarten

Slovakia

Slovenia

Somalia

South Africa

South Sudan

Spain

Sri Lanka

St. Barth

St. Vincent Grenadines

Sudan

Suriname

Sweden

Switzerland

Syria

Taiwan

Tajikistan

Tanzania

Thailand

Timor-Leste

Togo

Trinidad and Tobago

Tunisia

Turkey

Turks and Caicos

UAE

Uganda

UK

Ukraine

Uruguay

USA

Uzbekistan

Vatican City

Venezuela

Vietnam

Western Sahara

Yemen

Zambia

Zimbabwe

Name, designation and address of contact person for public queries about the trial should be mentioned. Address should include contact numbers and email ID, along with affiliation of the local person (in case of multi-country trial) who will respond to general queries, including information about current recruitment status. This may or may not be the same as the contact person for scientific queries. Email ID should be personal and not a general ID (e.g. info@gmail.com), which may not be accessed regularly by the designated person.

*Sponsor

Type [Select]

Pharmaceutical industry

Research Institutions

Research Institution and hospital

Government funding agencies

Medical/health science, University/college

Others (Please specify)

Name

Email

Contact number

Address

The individual, organization, group, or other legal entity which takes responsibility for initiating, managing and/or financing a study. The Sponsor is responsible for ensuring that the trial is properly registered. The Sponsor may or may not be the main funder.

*Country(s) of recruitment

The countries from which participants will be are intended to be or have been recruited.

(Press & Hold Ctrl Key to Select Multiple Countries)

No. of Selected Countries: [Automatic generated]

Afghanistan

Albania

Algeria

Andorra

Angola

Anguilla

Antigua and Barbuda

Argentina

Armenia

Aruba

Australia

Austria

Azerbaijan

Bahamas

Bahrain

Bangladesh

Barbados

Belarus

Belgium

Belize

Benin

Bermuda

Bhutan

Bolivia

Bosnia and Herzegovina

Botswana

Brazil

British Virgin Islands

Brunei

Bulgaria

Burkina Faso

Burundi

Cabo Verde

Cambodia

Cameroon

Canada

CAR

Caribbean Netherlands

Cayman Islands

Chad

Channel Islands

Chile

China

Colombia

Comoros

Congo

Costa Rica

Croatia

Cuba

Curaçao

Cyprus

Czechia

Denmark

Diamond Princess

Djibouti

Dominica

Dominican Republic

DRC

Ecuador

Egypt

El Salvador

Equatorial Guinea

Eritrea

Estonia

Eswatini

Ethiopia

Faeroe Islands

Falkland Islands

Fiji

Finland

France

French Guiana

French Polynesia

Gabon

Gambia

Georgia

Germany

Ghana

Gibraltar

Greece

Greenland

Grenada

Guadeloupe

Guatemala

Guinea

Guinea-Bissau

Guyana

Haiti

Honduras

Hong Kong

Hungary

Iceland

India

Indonesia

Iran

Iraq

Ireland

Isle of Man

Israel

Italy

Ivory Coast

Jamaica

Japan

Jordan

Kazakhstan

Kenya

Kuwait

Kyrgyzstan

Laos

Latvia

Lebanon

Lesotho

Liberia

Libya

Liechtenstein

Lithuania

Luxembourg

Macao

Madagascar

Malawi

Malaysia

Maldives

Mali

Malta

Martinique

Mauritania

Mauritius

Mayotte

Mexico

Moldova

Monaco

Mongolia

Montenegro

Montserrat

Morocco

Mozambique

MS Zaandam

Myanmar

Namibia

Nepal

Netherlands

New Caledonia

New Zealand

Nicaragua

Niger

Nigeria

North Macedonia

Norway

Oman

Pakistan

Palestine

Panama

Papua New Guinea

Paraguay

Peru

Philippines

Poland

Portugal

Qatar

Romania

Russia

Rwanda

Réunion

S. Korea

Saint Kitts and Nevis

Saint Lucia

Saint Martin

Saint Pierre Miquelon

San Marino

Sao Tome and Principe

Saudi Arabia

Senegal

Serbia

Seychelles

Sierra Leone

Singapore

Sint Maarten

Slovakia

Slovenia

Somalia

South Africa

South Sudan

Spain

Sri Lanka

St. Barth

St. Vincent Grenadines

Sudan

Suriname

Sweden

Switzerland

Syria

Taiwan

Tajikistan

Tanzania

Thailand

Timor-Leste

Togo

Trinidad and Tobago

Tunisia

Turkey

Turks and Caicos

UAE

Uganda

UK

Ukraine

Uruguay

USA

Uzbekistan

Vatican City

Venezuela

Vietnam

Western Sahara

Yemen

Zambia

Zimbabwe

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Part 2

*Site(s) of study

Site(s) of study

Site address

Contact person

Email

Contact number

Add new options for multicentric trial

For example

Site(s) of study

Site address

Contact person

Email

Contact number

Make symbol (+) than (?) done

List all site/s within the country including the site address as well as the name, complete address, email, telephone number of the responsible contact person at each site.

For multi-country trials list all site/s within Nepal including the site address as well as the complete address, email, telephone number of the responsible contact person at each site.

Presentation should be one that enables a patient or volunteer to be able to reach a designated site without difficulty. The designated person at the site should be a qualified person. The PI in whose name the Ethics approval has been issued should be included at the site, or else in any of the other contact person details, (PI or Trial Coordinator, contact person (scientific query).

*Ethical approval

Name of ethics committee

*Status Select

Submitted/ Under review

Approved

Not applicable

No objection certificate

Date of approval (Calendar)

Document (choose file) upload

The ethics review process information of the trial record in the primary register database.

Status (possible values: Not approved, Approved, Not Available)

Date of approval

Name and contact details of the Ethics committee(s)

a. Name

b. Contact details: address, phone, email

If more add new button for the Name of the ethics committee

*Health condition [Select]

Healthy human volunteers

Particular health condition(s) or problem(s)

Disease name [Missing this part, please add]

Write disease code (According to ICD 11)

Primary health condition(s) or problem(s) studied (e.g., Hypertension, Oral cancer). If the study is conducted in healthy human volunteers belonging to the target population of the intervention (e.g. preventive or screening interventions), enter the particular health condition(s) or problem(s) being prevented. If the study is conducted in healthy human volunteers not belonging to the target population (e.g., a preliminary safety study)

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Part 3

*Study type

Thesis

Yes

No

Not applicable

*Type of trial

Observational

Interventional

Others (Specify)

*Type of study

If observational

Cross-sectional study [Spelling mistake]

Follow up study

Case-control study

Cohort study

Others (Specify)

If Interventional

Preventive

Screening

Drug

Vaccine

Stem cell therapy

Medical devices

Surgical anesthesia

Radiation therapy

Diagnostic

Dentistry

Physiotherapy

Behavioral

Traditional/Complementary medicine

Others (Specify)

[Give options for multiple choices]

Please indicate the trial part of the thesis (please select the appropriate option) Please select whether the trial is an interventional trial, Observational trial.

Interventional Trial: An interventional trial is one that prospectively assigns human participants or groups of humans to one or more health-related intervention to evaluate the effect on outcomes.

Choose the intervention that is best suited for the trial; more than one option may be selected according to the intervention/s being used; e.g. Drug & Traditional/Complementary medicine

Observational Trial: An observational trial is one where no experimental intervention or treatment is given to human participants. In this type of trial, the investigator only observes the effect of a risk factor, diagnostic test, or treatment on a particular outcome. Choose the intervention that is best suited for the trial.

*Study design

allocation

§ single-arm study

§ randomized controlled trial

§ non-randomized controlled trial

masking

§ open (masking not used)

§ blinded (masking used)

■Registries may collect data on who is masked (the subjects, therapist or clinician, assessor or data analyst) and/or use the terms double blind or single-blind.

control

§ placebo

§ active

§ uncontrolled

§ historical

§ dose comparison

assignment

§ single

§ parallel

§ crossover

§ factorial

§ cluster

§ other

Purpose

§ treatment

§ prevention

§ diagnostic

§ supportive care

§ screening

§ health services research

§ basic science

§ other

Trial Phase

o N/A

o 0 (exploratory trials)

o 1

o 1-2

o 2

o 2-3

o 3

o 4

Intervention and comparison

Intervention name

Intervention details

Comparison name

Comparison details

Enter the specific name of the intervention(s) and the comparator/control(s) being studied. Use the International Non-Proprietary Name if possible (not brand/trade names). For an unregistered drug, the generic name, chemical name, or company serial number is acceptable. If the intervention consists of several separate treatments, list them all in one line separated by commas (e.g., "low-fat diet, exercise").

The control intervention(s) is/are the interventions against which the study intervention is evaluated (e.g., placebo, no treatment, active control). If an active control is used, be sure to enter in the name(s) of that intervention, or enter "placebo" or "no treatment" as applicable.

For each intervention, describe other intervention details as applicable (dose, duration, mode of administration, etc.)

*Inclusion criteria

Age [From .. To]

Gender

Female

Male

Both

Others

*Exclusion criteria

Details

Inclusion and exclusion criteria for participant selection, including age and sex. Age and sex are to be mentioned in specific boxes.

*Primary outcome

Outcome

Timepoint

Outcomes are events, variables, or experiences that are measured because it is believed that they may be influenced by the intervention. The primary outcome could be the outcome used in the sample size calculations or the main outcome/s used to determine the effects of the intervention/s. Enter the names of all primary outcomes in the trial as well as the pre-specified time point/s of primary interest. Be as specific as possible.

All of the data for a primary outcome should be provided to the WHO Search Portal in a single line.

Secondary outcome

Outcome

Timepoint

The secondary outcome may involve the same event, variable, or experience as the primary outcome, but measured at time-points other than those of primary interest (e.g., Primary outcome: all-cause mortality at 10 years; Secondary outcome: all-cause mortality at 2 years, 5 years), or may involve a different event, variable, or experience altogether (e.g., Primary outcome: all-cause mortality at 5 years; Secondary outcome: hospitalization rate at 5 years). Enter the name and time-point(s) for all secondary outcomes of clinical and/or scientific importance.

*Sample size: Details

Number of participants that this trial plans to enroll. Ideally, this item should be a number only without any textual description. Number of participants that a trial has enrolled.

*Date of first enrollment (Calendar)

Select the anticipated or actual date of enrollment of the first participant. Please, provide at least the month and year, preferably provide a complete date.

*Study completion date (Calendar)

The date of study completion: The date on which the final data for a clinical study were collected (commonly referred to as, "last subject, last visit").

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Part 4

*Enrollment status

Ø Pending

Ø Recruiting

Ø Suspended

Ø Withdrawn

Complete

●Complete: follow-up continuing

●Complete: follow-up complete

●Other (Specify)

Summary Results (After completion of trial) (done)

Date of posting of results summaries

Date of the first journal publication of results

URL hyperlink(s) related to results and publications

Baseline Characteristics: Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age and sex, and study-specific measures.

Participant flow: Information to document the progress and numbers of research participants through each stage of a study in a flow diagram or tabular format.

Adverse events: An unfavorable change in the health of a participant, including abnormal laboratory findings, and all serious adverse events and deaths that happen during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied.

Outcome measures: A table of data for each primary and secondary outcome measure and their respective measurement of precision (e.g. a 95% confidence interval) by arm (that is, the initial assignment of participants to arms or groups) or the comparison group (that is, analysis groups), including the result(s) of scientifically appropriate statistical analyses that were performed on the outcome measure data, if any.

URL link to protocol file(s) with version and date

Brief Summary

Publication details

Report, Article

Upload

Include publications details (URL/Reference), If any

*Individual clinical trial Participant-Level (IPD) sharing

Statement regarding the intended sharing of de-identified individual clinical trial participant-level data (IPD). Should indicate whether or not IPD will be shared, what IPD will be shared, when, by what mechanism, with whom and for what types of analyses.

Do you plan to share IPD?

Yes

No

Not decided

Plan description

Data availability

Date of posting (Calendar)

Date of study completion (Calendar)

Final sample size

Date of first publication (Calendar)

URL of the result/Publication

*Disclaimer

*I agree to inform the NPCTR of any changes made to the trial protocol.

* I agree to provide regular progress reports at 6 months, one year and yearly thereafter until the trial is complete.

*Supporting documents

Upload letter confirming institutional affiliation

Upload letter provided by supervisor (For thesis)

*Upload CV of PI

Upload other supporting documents

Progress report

For adverse events report

Final report

IPD

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Submit the trial