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Mahesh M ★ India, 2014-01-20 12:19 (4540 d 06:26 ago) Posting: # 12200 Views: 3,113 |
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Dear All, Is it required to mention Pilot or Pivotal study in protocol (protocol Title) ? Eg "Comparative, Open Label, Randomized, Single Dose, Two Way Crossover PILOT or PIVOTAL Bioavailability Study of...." Regards Mahesh M |
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kumarnaidu ★ Mumbai, India, 2014-01-20 14:35 (4540 d 04:11 ago) @ Mahesh M Posting: # 12201 Views: 2,766 |
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Hi Mahesh, ❝ Is it required to mention Pilot or Pivotal study in protocol (protocol Title) ? I think in pivotal studies we don't need to specify but in pilot studies we generally write in sample size section that this much sample size (generally 12) will be considered for the pilot study. — Kumar Naidu |
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Helmut ★★★   Vienna, Austria, 2014-01-20 14:59 (4540 d 03:47 ago) @ kumarnaidu Posting: # 12202 Views: 2,706 |
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Hi Mahesh and Kumar, ❝ ❝ Is it required to mention Pilot or Pivotal study in protocol (protocol Title) ? ❝ ❝ I think in pivotal studies we don't need to specify… Agree. ❝ … but in pilot studies we generally write in sample size section that this much sample size (generally 12) will be considered for the pilot study. We once had a case, where the Austrian authority – although “pilot study” was stated in the title – after submitting the protocol asked why we designed the study for such a small sample size. Obviously they did not read the title and neither comprehend the study’s objective nor the sample size section. BTW, why “generally 12”? What’s so particular about a dozen? — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz