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Comparative Understanding Level of Clinical Research Participants between SIDCER Informed Consent Form and Conventional Informed Consent Form at Thammasat 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 Thammasat Hospital, Thammasat University

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004817
Enrollment
Unknown
Registered
2014-06-19
Start date
2014-06-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Informed Consent in Clinical Trial

Interventions

1:SIDCER Informed Consent Form
2:Conventional Informed Consent Form

Sponsors

Institute of Tropical Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Clinical trial with intervention involving human subjects aged more than 18 years old that the protocol and informed consent process have been approved by the EC of TU; and 2) The study that the planned number of subjects is at least 10 individuals.

Exclusion criteria

Exclusion criteria: 1) The study involving patients with psychological, neurological or visual disorder; 2) The study with no written ICF; and 3) The study that the principal investigator (PI) refuses to coordinate or the sponsor does not allow the ICF study team to access the clinical study protocol and ICF.

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this study is the proportion of study participants who have post-test score of =80%.;The secondary endpoints are the total score of post-test, score of each category of elements required and time spent for all processes in each group.;—

Countries

Thailand

Contacts

Public ContactThipaporn Tharavanij

Thammasat University

thipaporn_t@yahoo.com+66-2926-9794

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026