WHO guidance on good data and record management practices

Definition of the term (“What is the WHO Good Practice Guideline for Data and Records Management?”)

The WHO Good Prac­ti­ce Gui­de­line for Data and Re­cords Ma­nage­ment is of ut­most si­gni­fi­can­ce to the he­alth­ca­re in­dus­try as it sets stan­dards and re­com­men­da­ti­ons that en­su­re the qua­li­ty and in­te­gri­ty of data and re­cords in me­di­cal re­se­arch and prac­ti­ce. The gui­de­line con­ta­ins de­tail­ed and clear ex­pl­ana­ti­ons on im­ple­men­ta­ti­on and, thus, clo­ses sup­po­sed gaps in other gui­de­lines. It also ex­plains how the re­gu­la­to­ry re­qui­re­ments af­fect prac­ti­ce and what should be de­mons­tra­b­ly im­ple­men­ted to meet all re­qui­re­ments. In par­ti­cu­lar, the ap­pli­ca­ti­on of data ma­nage­ment pro­ce­du­res will be ad­dres­sed. It is fun­da­men­tal­ly spe­ci­fied to use a sys­te­ma­tic ap­proach which gua­ran­tees that all GxP re­cords are com­pre­hen­si­ve and re­lia­ble du­ring the en­ti­re lifecycle.

The significance of data and records management

  • Data and re­cords in the he­alth­ca­re in­dus­try:  The he­alth­ca­re in­dus­try re­li­es hea­vi­ly on ac­cu­ra­te and re­lia­ble data and re­cords. This in­for­ma­ti­on is cru­cial for di­se­a­se dia­gno­sis, tre­at­ment and re­se­arch. The WHO Good Prac­ti­ce Gui­de­line for Data and Re­cords Ma­nage­ment aims to im­pro­ve the qua­li­ty of the­se data and records. 
  • Trust in data Trust in the ac­cu­ra­cy and in­te­gri­ty of he­alth data and re­cords is of grea­test im­portance to doc­tors, re­se­ar­chers, and pa­ti­ents. The WHO gui­de­line helps to build this confidence. 
  • Re­se­arch and de­ve­lo­p­ment High-qua­li­ty data is es­sen­ti­al in me­di­cal re­se­arch. The gui­de­line sup­ports best prac­ti­ce in data ma­nage­ment in or­der to im­pro­ve the qua­li­ty of re­se­arch results.

What does the guideline contain?

  • Data ma­nage­ment gui­de­lines:  The gui­de­line pro­vi­des clear gui­de­lines for data ma­nage­ment, in­clu­ding data coll­ec­tion, sto­rage, and trans­mis­si­on. The­se gui­de­lines aim to en­su­re that data is re­cor­ded and stored correctly. 
  • Se­cu­ri­ty stan­dards:  The se­cu­ri­ty of he­alth data is of ut­most si­gni­fi­can­ce. The gui­de­line es­tab­lishes se­cu­ri­ty stan­dards to en­su­re the pro­tec­tion of sen­si­ti­ve information. 
  • Trai­ning:  Trai­ning is ne­ces­sa­ry to suc­cessful­ly im­ple­ment the guideline. 

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Why is this guideline important?

The WHO Good Prac­ti­ce Gui­de­line on Data and Re­cords Ma­nage­ment is of ma­jor im­portance for se­ve­ral reasons:

  • Qua­li­ty assu­rance: It en­su­res the qua­li­ty of he­alth data and records. 
  • Trust: It builds con­fi­dence in the ac­cu­ra­cy and in­te­gri­ty of he­alth information. 
  • Re­se­arch fun­ding: It pro­mo­tes high-qua­li­ty re­se­arch and de­ve­lo­p­ment in medicine. 
  • Pro­tec­ting sen­si­ti­ve in­for­ma­ti­on: It en­su­res the se­cu­ri­ty and pro­tec­tion of sen­si­ti­ve he­alth data. 
  • Im­pro­ved pa­ti­ent care: It helps to im­pro­ve pa­ti­ent care by pro­vi­ding doc­tors and me­di­cal staff with ac­cu­ra­te data.

Why is chapter 7 of the WHO guideline so important?

Chap­ter 7 of the gui­de­line deals with con­trac­ting com­pa­nies, sup­pli­ers, and ser­vice pro­vi­ders. Due to the in­cre­asing as­sign­ment of GxP tasks, it is ne­ces­sa­ry, ac­cor­ding to the WHO, to de­fi­ne and con­sis­t­ent­ly ma­na­ge ro­les and re­spon­si­bi­li­ties. The se­cu­ri­ty of the com­pre­hen­si­ve and cor­rect data and re­cords du­ring the working re­la­ti­onship must be mu­tual­ly gua­ran­teed. The re­spon­si­ble par­ties of the con­trac­ting en­ti­ty and con­trac­tor shall com­pre­hen­si­ve­ly de­ter­mi­ne which pro­ces­ses must be in­itia­ted to en­su­re the in­te­gri­ty of the data. The­se de­tails should be in­cluded in a con­tract to be con­cluded for the out­sour­ced work.

What if the deployment of the software is outsourced?

If the pro­vi­si­on of da­ta­ba­ses and soft­ware is out­sour­ced, the con­trac­ting en­ti­ty must make sure that the con­trac­tors are ap­pro­ved, spe­ci­fied in the qua­li­ty agree­ment, and ade­qua­te­ly qua­li­fied and trai­ned in the GxP en­vi­ron­ment. The out­sour­ced ac­ti­vi­ties must be mo­ni­to­red re­gu­lar­ly and the con­trol­ling in­ter­vals must be spe­ci­fied as part of the risk evaluation.

Conclusion

The WHO Good Prac­ti­ce Gui­de­line for Data and Re­cords Ma­nage­ment is a mi­le­stone in the he­alth­ca­re in­dus­try. It sets stan­dards that im­pro­ve the qua­li­ty and se­cu­ri­ty of he­alth data and in­crease trust in that data. The im­ple­men­ta­ti­on of this gui­de­line is cri­ti­cal to the fu­ture of me­di­cal re­se­arch and practice.

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Frequently Asked Questions (FAQs)

Who ad­he­re to the gui­de­line?
The gui­de­line should be fol­lo­wed by all he­alth­ca­re pro­fes­sio­nals in­vol­ved in the coll­ec­tion and ma­nage­ment of he­alth data and records.

Does the gui­de­line ap­p­ly world­wi­de?
Yes, the WHO gui­de­line ap­pli­es world­wi­de and sets in­ter­na­tio­nal stan­dards for data and re­cords management.

Are the­re pe­n­al­ties for non-com­pli­ance with the gui­de­line?
The gui­de­line does not spe­ci­fy any par­ti­cu­lar pe­n­al­ties, but com­pli­ance is stron­gly re­com­men­ded to en­su­re the qua­li­ty and in­te­gri­ty of he­alth data.

How can he­alth­ca­re fa­ci­li­ties im­ple­ment the gui­de­line?
He­alth­ca­re fa­ci­li­ties should or­ga­ni­ze trai­ning and edu­ca­ti­on for their staff to suc­cessful­ly im­ple­ment the guideline.

Are the­re re­sour­ces to help to im­ple­ment the gui­de­line?
Yes, WHO of­fers trai­ning ma­te­ri­als and re­sour­ces to fa­ci­li­ta­te the im­ple­men­ta­ti­on of the guideline.

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ISO certification

De­fi­ni­ti­on of the term (“What does ISO cer­ti­fi­ca­ti­on mean?”)  The ISO cer­ti­fi­ca­ti­on is a pro­ce­du­re that ser­ves the pur­po­se of de­mons­t­ra­ting com­pli­ance with cer­tain requirements.

GxP

De­fi­ni­ti­on of the term (“What is GxP?”) GxP, short for “Good Prac­ti­ces,” is a coll­ec­ti­ve term that en­com­pas­ses va­rious re­gu­la­ti­ons, stan­dards and gui­de­lines that con­trol the