Clinical Research Associate Indonesia

An Independent Source of Clinical Trials Conduct in Indonesia

Online Clinical Data Management service help in improving data collection and data quality in a developing country setting (Indonesia)

Can an Online Clinical Data Management service help in improving data collection and data quality in a developing country setting?

Maarten A Wildeman emailJeroen Zandbergen emailAndrew Vincent emailCamelia Herdini emailJaap M Middeldorp emailRenske Fles emailOtilia Dalesio emailEmile van der Donk email and I. BING Tan email

Trials 2011, 12:190doi:10.1186/1745-6215-12-190

Published: 8 August 2011

Data collection by Electronic Medical Record (EMR) systems have been proven to be helpful in data collection for scientific research and in improving healthcare. For a multi-centre trial in Indonesia and the Netherlands a web based system was selected to enable all participating centres to easily access data. This study assesses whether the introduction of a Clinical Trial Data Management service (CTDMS) composed of electronic Case Report Forms (eCRF) can result in effective data collection and treatment monitoring.

Methods

Data items entered were checked for inconsistencies automatically when submitted online. The data were divided into primary and secondary data items. We analysed both the total number of errors and the change in error rate, for both primary and secondary items, over the first five month of the trial.

Results

In the first five months 51 patients were entered. The primary data error rate was 1.6%, whilst that for secondary data was 2.7 % against acceptable error rates for analysis of 1% and 2.5% respectively.

Conclusion

The presented analysis shows that after five months since the introduction of the CTDMS the primary and secondary data error rates reflect acceptable levels of data quality. Furthermore, these error rates were decreasing over time. The digital nature of the CTDMS, as well as the online availability of that data, gives fast and easy insight in adherence to treatment protocols. As such, the CTDMS can serve as a tool to train and educate medical doctors and can improve treatment protocols.

Self-learning on Clinical trials in Resource-limited setting

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FCR – FDA Good Clinical Practice GCP Q&A

Search 2,600+ FDA answers to questions about Good Clinical Practice, clinical research regulations, and guidelines (years 2002-2007)

FCR – FDA Good Clinical Practice GCP Q&A.

A gold elixir of youth in the 16th century French court — Charlier et al. 339: b5311 — BMJ

To be pretty is expensive. Wonder how much will it cost to be Healthy…

A gold elixir of youth in the 16th century French court — Charlier et al. 339: b5311 — BMJ.

Directory of cancer drugs could help match treatments to tumours – Times Online

Directory of cancer drugs could help match treatments to tumours – Times Online

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Top 10 Cancers in Indonesia 2003 – 2008

Code
Site Of Cancer
n
Percentage
C50
Breast, NOS
2249
26.94
C53
Cervix uteri
1735
20.78
C11
Nasopharynx, NOS
1010
12.1
C77
Lymph nodes of head, face and neck
785
9.4
C34
Lung, NOS
656
7.86
C44
Skin of other and unspecified parts of face
563
6.74
C42
Bone marrow
415
4.97
C49
Overlapping lesion of connective, subcutaneous and other soft tissue
346
4.14
C56
Ovary
323
3.87
C18
Descending colon
267
3.2
   
8349
100

 

Source : www.rekanindo.org, accessed 13 Aug 2008