How to facilitate the documenting process in clinical trials

Do you have col­leagues and employ­ees who con­sid­er doc­u­ment­ing a time con­sum­ing and demand­ing activ­i­ty? Why does it hap­pen and which mea­sures can be tak­en to change this perception?

We work in clin­i­cal research, an envi­ron­ment which is nec­es­sar­i­ly high-reg­u­lat­ed. How­ev­er, we often for­get how much effort it took to estab­lish reg­u­la­tions for clin­i­cal tri­als and mar­ket approval.

Let´s look back to the 1961–1962, when the Con­ter­gan sleep­ing pills pre­scribed to preg­nant women were found out to cause limbs mal­for­ma­tions to unborn chil­dren. Or even fur­ther in time, when cru­el exper­i­ments were car­ried out dur­ing the 2nd World War or when in 1937 the untest­ed “med­i­cine” for­mu­la­tion of sul­fanil­amide and the tox­ic addi­tive dieth­yl­ene gly­col led to the death of 107 peo­ple in USA.

These and oth­er trag­i­cal events from the past cre­at­ed over time the aware­ness to con­trol and reg­u­late more and more clin­i­cal research, to reduce the risk that the his­to­ry will be repeat­ed. The Good Clin­i­cal Prac­tices (GCP) were there­fore cre­at­ed, allow­ing to devel­op stan­dards focused also on eth­i­cal and tech­ni­cal aspects and to guar­an­tee the safe­ty of par­tic­i­pants and the integri­ty of data.

Fur­ther­more, the process to devel­op a mol­e­cule into a final prod­uct ready for the mar­ket is expen­sive, time-con­sum­ing and it entails many required steps, each of which must be trace­able. This is why doc­u­ment­ing each process step in a com­plete man­ner can ensure the need­ed trans­paren­cy, for which the ALCOA and ALCOA plus prin­ci­ple have been estab­lished and proven in practice.

The doc­u­men­ta­tion of each project starts with the appro­pri­ate agree­ments to define tasks and respon­si­bil­i­ties, the design, the data type and how to col­lect them, the sta­tis­ti­cal meth­ods to use and the rel­e­vant project man­age­ment. The next steps cov­er the tasks for the clin­i­cal study/investigations in the clin­i­cal site, the data man­age­ment, the sta­tis­tic eval­u­a­tion and the writ­ing of a final report.

Audits/inspections will then ver­i­fy if the doc­u­men­ta­tion is avail­able and if the require­ments are ful­filled as per the applic­a­ble regulations.

As Qual­i­ty Man­ag­er I see myself respon­si­ble not only for trans­mit­ting infor­ma­tion and reg­u­la­to­ry require­ments, but also for rais­ing aware­ness between employ­ees. In this sense, it is par­tic­u­lar­ly impor­tant to trans­fer the rea­sons behind the inten­sive doc­u­ment­ing process.

There­fore, a per­son able to under­stand this effort and to inter­nalise the fact that sub­jects´ safe­ty and data integri­ty are at the fore­front, won´t ques­tion the effort itself and will be ready to imple­ment the doc­u­ment­ing process in an ade­quate manner.

It´s for this pur­pose that each year at ICRC-Wey­er we attend a GCP Train­ing, which main­ly focus­es on eth­i­cal aspects as those cov­ered by the Dec­la­ra­tion of Helsin­ki, the GCP prin­ci­ples of ICH E6 and DIN EN ISO 14155 as well as fur­ther clin­i­cal research require­ments and respon­si­bil­i­ties like the ALCOA+ principle.

Maria Schulz, Qual­i­ty Man­ag­er and Author
Viviana Ler­ario, Tech­ni­cal Editor