Comparison of SIDCER informed consent and conventional informed consent in understanding of potential participants of clinical trials at Phramongkutklao hospital

An Open-label, Randomized-controlled Trial of SIDCER Informed Consent Form and Conventional Informed Consent Form in Understanding of Potential Participants of Clinical Trials Conducted at Phramongkutklao Hospital

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

TCTR

Registry ID

TCTR20140930001

Enrollment

550

Registered

2014-09-30

Start date

2015-03-02

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

No health&#45

Interventions

It is a new informed consent form.,It is a conventional informed consent form.

Experimental Other,Experimental Other

SIDCER ICF,Conventional ICF

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: A potential participant who is invited to take part in recruited clinical trials at Phramongkutklao hospital.

Exclusion criteria

Exclusion criteria: A subject who refuses to take part in the informed consent process along with the procedure of understanding evaluation by the post-test questionnaire; or a subject who cannot read and write Thai.

Design outcomes

Primary

Measure	Time frame
The proportion of study participants who have post-test score of â‰¥80% None Post-test questionnaire	—

Secondary

Measure	Time frame
The total score of post-test None Post-test questionnaire,Score of each category of elements required None Post-test questionnaire,Time spent for all processes None Post-test questionnaire	—

Countries

Thailand

Contacts

Public ContactChanchai Traivaree

Phramongkutklao hospital, Bangkok, Thailand

ctrivaree@yahoo.com0817556677

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026